510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K012820Substantially Equivalent

Aia-Pack Ctni 2Nd-Gen Assay

Tosoh Medics, Inc., South San Francisco CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K012820 is the FDA 510(k) clearance record for AIA-PACK CTNI 2ND-GEN ASSAY, a class II device, cleared for Tosoh Medics, Inc. on under FDA product code MMI (Immunoassay Method, Troponin Subunit). FDA records list 41 510(k) clearances for Tosoh Medics, Inc., from to . As of , FDA records show one recall naming K012820.

Clearance record

Decision date
Received
(113 days to decision)
Product code
MMI Immunoassay Method, Troponin Subunit
Regulation
21 CFR 862.1215
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Tosoh Medics, Inc. 347 Oyster Pt. Blvd.,, South San Francisco CA
510(k) summary
Statement
Third party review
No

Clearances, product code MMI

Trailing 12 months
1 clearance under product code MMI in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MMI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260