510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K853803Substantially Equivalent

Fetal Bovine/fetal Calf Serum, Newborn, Horse, Rab

Z.L. Bocknek Laboratories, Inc., Canada Maw In1, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853803 is the FDA 510(k) clearance record for FETAL BOVINE/FETAL CALF SERUM, NEWBORN, HORSE, RAB, a class I device, cleared for Z.L. Bocknek Laboratories, Inc. on under FDA product code KIS (Sera, Animal And Human). FDA records list one 510(k) clearance for Z.L. Bocknek Laboratories, Inc. As of , FDA records show no recalls naming K853803.

Clearance record

Decision date
Received
(34 days to decision)
Product code
KIS Sera, Animal And Human
Regulation
21 CFR 864.2800
Device class
Class I
Review panel
Hematology
Applicant
Z.L. Bocknek Laboratories, Inc. 165 Bethridge Rd., Canada Maw In1, CA
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