510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K012053Substantially Equivalent

Diamedix Is-Anti-Cardiolipin Screen Test System

Diamedix Corp., Miami FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K012053 is the FDA 510(k) clearance record for DIAMEDIX IS-ANTI-CARDIOLIPIN SCREEN TEST SYSTEM, a class II device, cleared for Diamedix Corp. on under FDA product code MID (System, Test, Anticardiolipin Immunological). FDA records list 68 510(k) clearances for Diamedix Corp., from to . As of , FDA records show no recalls naming K012053.

Clearance record

Decision date
Received
(49 days to decision)
Product code
MID System, Test, Anticardiolipin Immunological
Regulation
21 CFR 866.5660
Device class
Class II
Review panel
Immunology
Applicant
Diamedix Corp. 2140 N. Miami Ave., 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