510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K940472Substantially Equivalent

Coxsackievirus B5 Monoclonal Antibody

Chemicon Intl., Inc., Temecula CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K940472 is the FDA 510(k) clearance record for COXSACKIEVIRUS B5 MONOCLONAL ANTIBODY, a class I device, cleared for Chemicon Intl., Inc. on under FDA product code GNM (Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6). FDA records list 8 510(k) clearances for Chemicon Intl., Inc., from to . As of , FDA records show no recalls naming K940472.

Clearance record

Decision date
Received
(583 days to decision)
Product code
GNM Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6
Regulation
21 CFR 866.3145
Device class
Class I
Review panel
Microbiology
Applicant
Chemicon Intl., Inc. 28835 Single Oak Dr., Temecula CA
510(k) summary
Summary
Third party review
No

Clearances, product code GNM

Trailing 12 months

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

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