510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K780697Substantially Equivalent

Goat Anti-Influenza Antisera Atexas

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

K780697 is the FDA 510(k) clearance record for GOAT ANTI-INFLUENZA ANTISERA ATEXAS, a class I device, cleared for Northeast Biomedical Labs., Inc. on under FDA product code GNS (Antisera, Hai, Influenza Virus A, B, C). FDA records list 9 510(k) clearances for Northeast Biomedical Labs., Inc., from to . As of , FDA records show no recalls naming K780697.

Clearance record

Decision date
Received
(9 days to decision)
Product code
GNS Antisera, Hai, Influenza Virus A, B, C
Regulation
21 CFR 866.3330
Device class
Class I
Review panel
Microbiology
Applicant
Northeast Biomedical Labs., Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code GNS

Trailing 12 months

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

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