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510(k) K760097

FEBRILE ANTIGENS & CONTROL SERUMS by Gamma Biologicals, Inc. — Product Code GSZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1976
Date Received
June 14, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, Febrile (Weil-Felix), All Groups
Device Class
Class I
Regulation Number
866.3410
Review Panel
MI
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)
  • K813342 — GAMMA CHLOROQUINE DIPHOSPHATE SOLUTION (March 4, 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)

Other clearances for product code GSZ

  • K885110 — PROTEUS OX-19 IFA* (August 15, 1989)
  • K760881 — FEBRILE ANTIGEN CONTROL SERA (November 9, 1976)