510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K780008Substantially Equivalent

Goat Anti-Influenza Antisera

Northeast Biomedical Labs., Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K780008 is the FDA 510(k) clearance record for GOAT ANTI-INFLUENZA ANTISERA, a class I device, cleared for Northeast Biomedical Labs., Inc. on under FDA product code GQT (Antisera, Cf, Parainfluenza Virus 1-4). FDA records list 9 510(k) clearances for Northeast Biomedical Labs., Inc., from to . As of , FDA records show no recalls naming K780008.

Clearance record

Decision date
Received
(17 days to decision)
Product code
GQT Antisera, Cf, Parainfluenza Virus 1-4
Regulation
21 CFR 866.3400
Device class
Class I
Review panel
Microbiology
Applicant
Northeast Biomedical Labs., Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code GQT

Trailing 12 months

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

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