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510(k) K932458

DOCUMENT ENZYME by Casco Standards — Product Code JJY

K932458 is an FDA 510(k) premarket notification submitted by Casco Standards for the device "DOCUMENT ENZYME". The FDA issued a decision of Substantially Equivalent on June 29, 1993. The device falls under product code JJY (Multi-Analyte Controls, All Kinds (Assayed)), a Class I device regulated under 21 CFR 862.1660. Casco Standards has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 1993
Date Received
May 21, 1993
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 Casco Standards

  • K981436 — DOCUMENT AMMONIA/ETHANOL/LACTATE CALIBRATOR, PN: M-109 (April 24, 1998)
  • K972904 — DOCUMENT MOLECULAR PATHOLOGY CHLAMYDIA TRACHOMATIS CONTROL (February 20, 1998)
  • K962629 — DOCUMENT AMMONIA, ETHANOL, LACTATE CALIBRATOR (September 13, 1996)
  • K961750 — DOCUMENT CARDIAC ASSAYED CONTROL (July 22, 1996)
  • K962630 — DOCUMENT AMMONIA, ETHANOL, LACTATE ASSAYED CONTROL (July 22, 1996)
  • K960244 — DOCUMENT TDM ULTRA ASSAYED CONTROL (March 22, 1996)
  • K955155 — DOCUMENT TDM ULTRA UNASSAYED CONTROL (December 20, 1995)
  • K950469 — DOCUMENT SERUM MULTIANALYTE CALIBRATION VERIFICATION TEST SET (April 11, 1995)
  • K945718 — DOCUMENT(R) HDL CHOLESTEROL CALIBRATION VERIFICATION TEST SET (January 17, 1995)
  • K945315 — DOCUMENT(R) AMMONIA/ETHANOL AQUEOUS CONTROL (December 9, 1994)

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