510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K780009Substantially Equivalent

Guinea Pig Whole Serum

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

K780009 is the FDA 510(k) clearance record for GUINEA PIG WHOLE SERUM, a class I device, cleared for Northeast Biomedical Labs., Inc. on under FDA product code KIS (Sera, Animal And Human). FDA records list 9 510(k) clearances for Northeast Biomedical Labs., Inc., from to . As of , FDA records show no recalls naming K780009.

Clearance record

Decision date
Received
(17 days to decision)
Product code
KIS Sera, Animal And Human
Regulation
21 CFR 864.2800
Device class
Class I
Review panel
Hematology
Applicant
Northeast Biomedical Labs., Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KIS

Trailing 12 months

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

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