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510(k) K954247

SYSCON CONTROL ASSAYED & UNASSAYED by Scantibodies Laboratory, Inc. — Product Code JJY

K954247 is an FDA 510(k) premarket notification submitted by Scantibodies Laboratory, Inc. for the device "SYSCON CONTROL ASSAYED & UNASSAYED". The FDA issued a decision of Substantially Equivalent on February 14, 1996. The device falls under product code JJY (Multi-Analyte Controls, All Kinds (Assayed)), a Class I device regulated under 21 CFR 862.1660. Scantibodies Laboratory, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 1996
Date Received
September 11, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Multi-Analyte Controls, All Kinds (Assayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

Other clearances by Scantibodies Laboratory, Inc.

  • K060578 — CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION) (August 30, 2006)
  • K060420 — MODIFICATION TO WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILLUMINOMETRIC (ICMA) ASSAY (March 1, 2006)
  • K060348 — MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT (February 27, 2006)
  • K051888 — TOTAL INTACT PTH IMMUNORADIOMETRIC ASSAY (COATED TUBE VERSION), MODEL 3KG013 (October 18, 2005)
  • K051810 — WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC ASSAY (IRMA) COATED TUBE KIT, MODEL (September 9, 2005)
  • K051141 — WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILUMINOMETRIC ASSAY (ICMA), MODEL 3KG002 (July 26, 2005)
  • K051150 — TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT (July 26, 2005)
  • K050748 — ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011 (May 20, 2005)
  • K031534 — CYCLASE ACTIVATING PTH (CAP) IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG001 (July 30, 2003)
  • K021032 — ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100 (June 3, 2002)

Other clearances for product code JJY

  • K162530 — Multichem IA Plus (March 31, 2017)
  • K163629 — Audit MicroControls Linearity FD Tumor Markers II (March 10, 2017)
  • K163015 — Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; (January 10, 2017)
  • K153712 — VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Veri (January 28, 2016)
  • K150300 — Liquichek Cardiac Markers Plus Control LT (December 11, 2015)
  • K142964 — VALIDATE Anemia Calibration Verification/ Linearity Test Kit (April 30, 2015)
  • K143379 — Liquichek Maternal Serum II Control (March 13, 2015)
  • K143573 — Audit MicroControls Linearity FD Tumor Markers II (January 16, 2015)
  • K140971 — LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3. (December 8, 2014)
  • K142978 — Audit MicroControls Linearity LQ Special Diabetes (November 20, 2014)

FDA data resources