510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K850003Substantially Equivalent

Coxsackie B Series Cf Antigens

Hillcrest Biologicals, Cypress CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K850003 is the FDA 510(k) clearance record for COXSACKIE B SERIES CF ANTIGENS, a class I device, cleared for Hillcrest Biologicals on under FDA product code GNG (Antigens, Cf (Including Cf Control), Coxsackievirus A 1-24, B 1-6). FDA records list 33 510(k) clearances for Hillcrest Biologicals, from to . As of , FDA records show no recalls naming K850003.

Clearance record

Decision date
Received
(62 days to decision)
Product code
GNG Antigens, Cf (Including Cf Control), Coxsackievirus A 1-24, B 1-6
Regulation
21 CFR 866.3145
Device class
Class I
Review panel
Microbiology
Applicant
Hillcrest Biologicals 10703 Progress Way, Cypress CA
Third party review
No

Clearances, product code GNG

Trailing 12 months

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

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