510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K032663Substantially Equivalent

Quantex Crp High Sensitivity Standard Multipoint, Quantex Crp High Sensitivity Controls Ve Controls 1/2

Instrumentation Laboratory Co., Bedford MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K032663 is the FDA 510(k) clearance record for QUANTEX CRP HIGH SENSITIVITY STANDARD MULTIPOINT, QUANTEX CRP HIGH SENSITIVITY CONTROLS VE CONTROLS 1/2, a class II device, cleared for Instrumentation Laboratory CO on under FDA product code DCK (C-Reactive Protein, Antigen, Antiserum, And Control). FDA records list 327 510(k) clearances for Instrumentation Laboratory CO, from to . As of , FDA records show no recalls naming K032663.

Clearance record

Decision date
Received
(113 days to decision)
Product code
DCK C-Reactive Protein, Antigen, Antiserum, And Control
Regulation
21 CFR 866.5270
Device class
Class II
Review panel
Immunology
Applicant
Instrumentation Laboratory CO 180 Hartwell Rd., Bedford MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DCK

Trailing 12 months

FDA records hold no clearances under product code DCK in the trailing twelve months.

FDA records show no clearances under product code DCK in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DCK, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260