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510(k) K810803

FREEZE DRIED PAPAIN by Biological Corp. of America — Product Code KSK

K810803 is an FDA 510(k) premarket notification submitted by Biological Corp. of America for the device "FREEZE DRIED PAPAIN". The FDA issued a decision of Substantially Equivalent on July 21, 1981. The device falls under product code KSK (Solution, Stabilized Enzyme), a Class II device regulated under 21 CFR 864.9400. Biological Corp. of America has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 1981
Date Received
March 24, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Solution, Stabilized Enzyme
Device Class
Class II
Regulation Number
864.9400
Review Panel
HE
Submission Type

Other clearances by Biological Corp. of America

  • K813404 — FREEZE DRIED FICIN (February 10, 1982)
  • K812565 — ELUTION SOLUTION (October 23, 1981)
  • K812222 — EM-X (September 23, 1981)
  • K781397 — EM-V (September 14, 1978)
  • K760162 — HEMATOLOGY CONTROL (August 4, 1976)

Other clearances for product code KSK

  • K813342 — GAMMA CHLOROQUINE DIPHOSPHATE SOLUTION (March 4, 1982)
  • K813404 — FREEZE DRIED FICIN (February 10, 1982)
  • K780962 — AUTOMATED ENZYME (July 27, 1978)
  • K760123 — AUTOZYME (July 20, 1976)

FDA data resources