510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K093955Substantially Equivalent

Anti-Hav Igm

Roche Diagnostics GmbH, Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K093955 is the FDA 510(k) clearance record for ANTI-HAV IGM, a class II device, cleared for Roche Diagnostics on under FDA product code LOL (Hepatitis A Test (Antibody And Igm Antibody)). FDA records list 465 510(k) clearances for Roche Diagnostics, from to . As of , FDA records show 2 recalls naming K093955.

Clearance record

Decision date
Received
(181 days to decision)
Product code
LOL Hepatitis A Test (Antibody And Igm Antibody)
Regulation
21 CFR 866.3310
Device class
Class II
Review panel
Microbiology
Applicant
Roche Diagnostics 9115 Hague Rd., Indianapolis IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LOL

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