510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K913618Substantially Equivalent

Arbovirus Igm Ifa Test

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

K913618 is the FDA 510(k) clearance record for ARBOVIRUS IGM IFA TEST, a class I device, cleared for Hillcrest Biologicals on under FDA product code GQC (Antisera, Cf, Equine Encephalitis Virus, Eee, Wee). FDA records list 33 510(k) clearances for Hillcrest Biologicals, from to . As of , FDA records show no recalls naming K913618.

Clearance record

Decision date
Received
(478 days to decision)
Product code
GQC Antisera, Cf, Equine Encephalitis Virus, Eee, Wee
Regulation
21 CFR 866.3240
Device class
Class I
Review panel
Microbiology
Applicant
Hillcrest Biologicals 10703 Progress Way, Cypress CA
510(k) summary
Summary
Third party review
No

Clearances, product code GQC

Trailing 12 months

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

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