510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K810803Substantially Equivalent

Freeze Dried Papain

Biological Corp. of America, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K810803 is the FDA 510(k) clearance record for FREEZE DRIED PAPAIN, a class II device, cleared for Biological Corp. of America on under FDA product code KSK (Solution, Stabilized Enzyme). FDA records list 6 510(k) clearances for Biological Corp. of America, from to . As of , FDA records show no recalls naming K810803.

Clearance record

Decision date
Received
(119 days to decision)
Product code
KSK Solution, Stabilized Enzyme
Regulation
21 CFR 864.9400
Device class
Class II
Review panel
Hematology
Applicant
Biological Corp. of America 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KSK

Trailing 12 months

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

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