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510(k) K863751

MULTI-ANALYTE LIN-TROL by Sigma Diagnostics, Inc. — Product Code JJY

K863751 is an FDA 510(k) premarket notification submitted by Sigma Diagnostics, Inc. for the device "MULTI-ANALYTE LIN-TROL". The FDA issued a decision of Substantially Equivalent on Nov 24, 1986. The device falls under product code JJY (Multi-Analyte Controls, All Kinds (Assayed)), a Class I device regulated under 21 CFR 862.1660. Sigma Diagnostics, Inc. has 163 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Nov 24, 1986
Date Received
Sep 25, 1986
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
510(k) Exempt

Other clearances by Sigma Diagnostics, Inc.

  • K021162 — AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX… (Aug 30, 2002)
  • K020109 — SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL (Feb 6, 2002)
  • K013549 — SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971 (Dec 26, 2001)
  • K013545 — SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221 (Nov 15, 2001)
  • K013544 — SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096 (Nov 15, 2001)
  • K012410 — INFINITY HBA KIT, MODELS 537-A, 537-B (Oct 26, 2001)
  • K010652 — SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936 (Mar 30, 2001)
  • K010158 — THROMBOMAX-HS WITH CALCIUM, MODEL T6540 (Mar 22, 2001)
  • K003267 — SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A (Mar 15, 2001)
  • K003328 — ACCUCLOT CONTROL I, MODEL A4089 (Mar 1, 2001)

Other clearances for product code JJY

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

FDA data resources

Source: FDA 510(k) database entry for K863751. Report a data issue: hello@regdatalab.com.