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510(k) K894261

TOXOPLASMA GONDII-CF ANTIGEN AND CONTROL ANTIGEN by Microbix Biosystems, Inc. — Product Code GMN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 1989
Date Received
June 21, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, Cf, Toxoplasma Gondii
Device Class
Class II
Regulation Number
866.3780
Review Panel
MI
Submission Type

Other clearances by Microbix Biosystems, Inc.

  • K894262 — RUBELLA ANTIGEN AND CONTROL ANTIGEN (October 16, 1989)
  • K852931 — HERPES HOMINUS I-COMPLE FIX ANTIGEN & NEGATIVE CLT (November 12, 1985)
  • K852930 — VARICELLA-ZOSTER-COMPLE FIX ANTIGEN AND NEG CONTRO (November 12, 1985)
  • K852932 — MEASLES-COMPLEMENT FIX ANTIGEN & NEGATIVE CLT (November 12, 1985)
  • K852929 — CMV-COMPLEMENT FIXATION ANTIGEN AND NEGATIVE CONTR (November 12, 1985)
  • K852933 — MYCOPLASMA SPP SEROLOGICAL REAGENTS (August 1, 1985)

Other clearances for product code GMN

  • K864981 — TOXOPLASMA GONDII (October 30, 1987)
  • K791456 — AGGLUTINOTEST-TOXOPLASMOSIS (September 24, 1979)