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510(k) K864981

TOXOPLASMA GONDII by Virion (U.S.), Inc. — Product Code GMN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 1987
Date Received
December 22, 1986
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 Virion (U.S.), Inc.

  • K933251 — EPSTEIN-BARR VIRUS COMBI TEST, EBV COMBI TEST (June 13, 1994)
  • K921618 — COXSACKIE VIRUS B1-B6 CF ANTIGENS (June 29, 1992)
  • K905306 — MUMPS COMPLEMENT-FIXATION (C.F.) ANTIGEN (June 17, 1991)
  • K905385 — P.I.V. COMPLEMENT-FIXATION (C.F.) ANTIGEN (March 21, 1991)

Other clearances for product code GMN

  • K894261 — TOXOPLASMA GONDII-CF ANTIGEN AND CONTROL ANTIGEN (October 16, 1989)
  • K791456 — AGGLUTINOTEST-TOXOPLASMOSIS (September 24, 1979)