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510(k) K802933

MUMPS S & V ANTIGENS & CONTROLS by Orion Diagnostica, Inc. — Product Code GRC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 31, 1980
Date Received
November 19, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, Cf (Including Cf Control), Mumps Virus
Device Class
Class I
Regulation Number
866.3380
Review Panel
MI
Submission Type

Other clearances by Orion Diagnostica, Inc.

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  • K042625 — QUIKREAD CRP CALIBRATOR SET (November 18, 2004)
  • K042442 — QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085; QUICKREAD 101 INSTRUMENT, MODE (September 24, 2004)
  • K942286 — DIARLEX ROTA-ADENO (December 14, 1994)
  • K914892 — SALIVA-STIM (September 2, 1992)
  • K904655 — PYLORISET (October 21, 1991)
  • K884074 — IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN G (October 27, 1988)
  • K884147 — IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN M (October 27, 1988)
  • K884075 — IMMUNOCHEMICAL DETERMINATION OF TRANSFERRIN (October 19, 1988)

Other clearances for product code GRC

  • K905306 — MUMPS COMPLEMENT-FIXATION (C.F.) ANTIGEN (June 17, 1991)
  • K832873 — MUMPS COMPLEMENT FIXATION & HEMAGGLU (December 27, 1983)