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510(k) K813404

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

K813404 is an FDA 510(k) premarket notification submitted by Biological Corp. of America for the device "FREEZE DRIED FICIN". The FDA issued a decision of Substantially Equivalent on February 10, 1982. 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
February 10, 1982
Date Received
December 7, 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

  • K812565 — ELUTION SOLUTION (October 23, 1981)
  • K812222 — EM-X (September 23, 1981)
  • K810803 — FREEZE DRIED PAPAIN (July 21, 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)
  • K810803 — FREEZE DRIED PAPAIN (July 21, 1981)
  • K780962 — AUTOMATED ENZYME (July 27, 1978)
  • K760123 — AUTOZYME (July 20, 1976)

FDA data resources