510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K844695Substantially Equivalent

Echo Type 4 Cf Antigen

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

K844695 is the FDA 510(k) clearance record for ECHO TYPE 4 CF ANTIGEN, a class I device, cleared for Hillcrest Biologicals on under FDA product code GNL (Antigens, Cf (Including Cf Control), Echovirus 1-34). FDA records list 33 510(k) clearances for Hillcrest Biologicals, from to . As of , FDA records show no recalls naming K844695.

Clearance record

Decision date
Received
(92 days to decision)
Product code
GNL Antigens, Cf (Including Cf Control), Echovirus 1-34
Regulation
21 CFR 866.3205
Device class
Class I
Review panel
Microbiology
Applicant
Hillcrest Biologicals 3780 Woodruff Ave., Long Beach CA
Third party review
No

Clearances, product code GNL

Trailing 12 months

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

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