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510(k) K872397

COBAS FP REAGENTS FOR PHENO & COBAS FP PHENO CALI. by Roche Diagnostic Systems, Inc. — Product Code LGQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 1987
Date Received
June 22, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorescence Polarization Immunoassay, Phenobarbital
Device Class
Class II
Regulation Number
862.3660
Review Panel
TX
Submission Type

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  • K983555 — ABUSCREEN ONLINE BENZ 200 CALIBRATORS (December 15, 1998)
  • K983556 — ABUSCREEN ONLINE BENZ 300 CALIBRATORS (December 15, 1998)
  • K983703 — MODIFICATION TO ABUSCREEN ONLINE FOR METHADONE (December 11, 1998)
  • K983697 — MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE (December 11, 1998)
  • K983699 — MODIFICATION TO ABUSCREEN ONLINE FOR AMPHETAMINES (December 11, 1998)
  • K983700 — MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE (December 11, 1998)
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Other clearances for product code LGQ

  • K972331 — INNOFLUOR GENTAMICIN ASSAY SYSTEM (August 1, 1997)
  • K972330 — INNOFLUOR PHENOBARBITAL ASSAY SYSTEM (July 14, 1997)
  • K940596 — AXSYM PHENOBARBITAL (June 21, 1994)
  • K936130 — COBAS-FP REAGENT FOR PHENOBARBITAL AND COBAS-FP PHENOBARBITAL CALIBRATORS (March 11, 1994)
  • K900704 — MODIFIED ACCUFLUOR PHENOBARBITAL REAGENT & CALIBRA (April 12, 1990)
  • K894525 — FPR PHENOBARBITAL KIT (August 28, 1989)
  • K863625 — PHENOBARBITAL-FPIA FLUORES. POLAR. IMMUNOASSAY KIT (November 10, 1986)
  • K862528 — IMMPULSE PHENOBARBITAL ASSAY REAGENTS (July 16, 1986)
  • K854044 — TDX BARBITURATES (October 28, 1985)
  • K843825 — COBAS REAGENTS PHENOBARBITAL & PHENOBAR (February 1, 1985)