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510(k) K864645

ADENOLEX (R) LATEX AGGLUTINATION TEST by Orion Diagnostica, Inc. — Product Code GOD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 1987
Date Received
November 25, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, Cf (Including Cf Control), Adenovirus 1-33
Device Class
Class I
Regulation Number
866.3020
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 GOD

  • K110722 — RPS ADENO DETECTOR PLUS (May 17, 2011)
  • K052092 — RPS ADENO DETECTOR (November 22, 2005)
  • K990630 — SAS ADENO TEST (August 19, 1999)
  • K972406 — ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEM (December 22, 1997)
  • K881894 — ADENOCLONE(R)-TYPE 40/41 EIA DIAGNOSTIC TEST (48) (July 8, 1988)
  • K873312 — ADENOCLONE(TM)-IFA, ADENOVIRUS ANTIGEN TEST (February 24, 1988)
  • K873082 — ADENOCLONE(TM)-EIA ADENOVIRUS ANTIGEN TEST (February 24, 1988)
  • K871229 — ANTIBODY ASSAY FOR DETECTION OF ADENOVIRUS IN CELL (June 26, 1987)
  • K843649 — ADENOVIRUS (September 26, 1985)
  • K802929 — ADENO VIRUS & CONTROLS (December 31, 1980)