510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K063319Substantially Equivalent

Monolisa Anti-Hav Igm Eia

Bio-Rad Laboratories Inc., Hauts-De-Seine, FR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K063319 is the FDA 510(k) clearance record for MONOLISA ANTI-HAV IGM EIA, a class II device, cleared for Bio-Rad Laboratories on under FDA product code LOL (Hepatitis A Test (Antibody And Igm Antibody)). FDA records list 128 510(k) clearances for Bio-Rad Laboratories, from to . As of , FDA records show no recalls naming K063319.

Clearance record

Decision date
Received
(182 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
Bio-Rad Laboratories 3 Bd Raymond Poincare, Hauts-De-Seine, FR
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 November 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LOL, trailing twelve months
MonthClearances
December 20250
January 20261
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260