510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K853156Substantially Equivalent

Echo Type 16 Cf Antigen

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

K853156 is the FDA 510(k) clearance record for ECHO TYPE 16 CF ANTIGEN, a class I device, cleared for Hillcrest Biologicals on under FDA product code GNK (Antisera, Cf, Echovirus 1-34). FDA records list 33 510(k) clearances for Hillcrest Biologicals, from to . As of , FDA records show no recalls naming K853156.

Clearance record

Decision date
Received
(100 days to decision)
Product code
GNK Antisera, Cf, Echovirus 1-34
Regulation
21 CFR 866.3205
Device class
Class I
Review panel
Microbiology
Applicant
Hillcrest Biologicals 10703 Progress Way, Cypress CA
Third party review
No

Clearances, product code GNK

Trailing 12 months

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

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