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510(k) K813342

GAMMA CHLOROQUINE DIPHOSPHATE SOLUTION by Gamma Biologicals, Inc. — Product Code KSK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 1982
Date Received
November 25, 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 Gamma Biologicals, Inc.

  • K864207 — DISPOSABLE TEST CARDS/GAMMA SLIDE TEST INFECT MONO (December 3, 1986)
  • K861016 — GAMMA SLIDE TEST FOR INFECTIOUS MONONUCLEOSIS (April 18, 1986)
  • K832473 — GAMMA SLIDE TEST FOR PREGNANCY (August 16, 1983)
  • K820647 — GAMMA FETAL BLEED SCREENING TEST (May 12, 1982)
  • K820072 — FE-CULT PLUS (March 4, 1982)
  • K811752 — FE-CULT PLUS (November 2, 1981)
  • K802533 — GAMMA LEWIS BLOOD GROUP SUBSTANCE (November 12, 1980)
  • K802534 — GAMMA PI BLOOD GROUP SUBSTANCE (November 12, 1980)
  • K800658 — RST-SERIES CONTROL (April 16, 1980)
  • K792583 — GAMMA ARACHIS HYPOGEA LECTIN (January 16, 1980)

Other clearances for product code KSK

  • K813404 — FREEZE DRIED FICIN (February 10, 1982)
  • K810803 — FREEZE DRIED PAPAIN (July 21, 1981)
  • K780962 — AUTOMATED ENZYME (July 27, 1978)
  • K760123 — AUTOZYME (July 20, 1976)