510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K982121Substantially Equivalent

Enzymatic Mitochondrial Antibody (M2) Reagent

Trace Scientific, Ltd., Miami FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K982121 is the FDA 510(k) clearance record for ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT, a class II device, cleared for Trace Scientific , Ltd. on under FDA product code DBM (Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control). FDA records list 55 510(k) clearances for Trace Scientific , Ltd., from to . As of , FDA records show no recalls naming K982121.

Clearance record

Decision date
Received
(93 days to decision)
Product code
DBM Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
Regulation
21 CFR 866.5090
Device class
Class II
Review panel
Immunology
Applicant
Trace Scientific , Ltd. 7260 NW 58th St., Miami FL
510(k) summary
Statement
Third party review
No

Clearances, product code DBM

Trailing 12 months

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

FDA records show no clearances under product code DBM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DBM, 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