510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K003069Substantially Equivalent

Anti-Cardiolipin, Multiple Autoantibodies Immunological Test System

Quest Intl., Inc., North Miami FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K003069 is the FDA 510(k) clearance record for ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM, a class II device, cleared for Quest Intl., Inc. on under FDA product code MID (System, Test, Anticardiolipin Immunological). FDA records list 25 510(k) clearances for Quest Intl., Inc., from to . As of , FDA records show no recalls naming K003069.

Clearance record

Decision date
Received
(56 days to decision)
Product code
MID System, Test, Anticardiolipin Immunological
Regulation
21 CFR 866.5660
Device class
Class II
Review panel
Immunology
Applicant
Quest Intl., Inc. 1938 NE 148th Terr., North Miami FL
510(k) summary
Summary
Third party review
No

Clearances, product code MID

Trailing 12 months

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

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