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510(k) K050536

QUEST DIAGNOSTICS IMMUNOASSAY/TDM CONTROL by Bio-Rad — Product Code JJY

K050536 is an FDA 510(k) premarket notification submitted by Bio-Rad for the device "QUEST DIAGNOSTICS IMMUNOASSAY/TDM CONTROL". The FDA issued a decision of Substantially Equivalent on Mar 24, 2005. The device falls under product code JJY (Multi-Analyte Controls, All Kinds (Assayed)), a Class I device regulated under 21 CFR 862.1660. Bio-Rad has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Mar 24, 2005
Date Received
Mar 2, 2005
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 Bio-Rad

  • K171061 — MRSASelect II (Dec 28, 2017)
  • K122187 — VRESELECT CULTURE MEDIUM (Nov 6, 2012)
  • K103684 — VRESELECT CULTURE MEDIUM (Oct 21, 2011)
  • K093678 — PLATELIA ASPERGILLUS EIA MODEL 62793 (Jan 13, 2011)
  • K100589 — MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS (Oct 29, 2010)
  • K081362 — PLATELIA LYME IGM (Jun 26, 2008)
  • K081212 — MRSASELECT - EXTENDED INCUBATION (Jun 13, 2008)
  • K080012 — PLATELIA LYME IGG ASSAY (May 8, 2008)
  • K070361 — MRSASELECT (Sep 13, 2007)
  • K060641 — PLATELIA ASPERGILLUS EIA, MODEL 62793 (Jun 2, 2006)

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 Veri (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