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510(k) K812985

AGGLUTEX MORPHINE TEST KIT by Hoffmann-La Roche, Inc. — Product Code DDF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 31, 1981
Date Received
October 26, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prothrombin, Antigen, Antiserum, Control
Device Class
Class I
Regulation Number
866.5735
Review Panel
HE
Submission Type

Other clearances by Hoffmann-La Roche, Inc.

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  • K831694 — RENAK (July 19, 1983)
  • K830461 — ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONE (March 24, 1983)
  • K830462 — ABUSCREEN RADIOUMMUNOASSAY--URINE (March 24, 1983)
  • K830460 — ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE (March 24, 1983)
  • K830481 — ABUSCREEN RADIOIMMUNOASSAY-PHENCYCLIDINE (March 24, 1983)
  • K830482 — ABUSCREEN RADIOIMMUNOASSAY-AMPHETAMINE (March 24, 1983)
  • K830480 — ABUSCREEN RADIOIMMUNOASSAY-COCAINE META (March 24, 1983)
  • K830479 — ABUSCREEN RADIOIMMUNOASSAY-BARBITURATE (March 10, 1983)
  • K823572 — COBAS STANDARDS FOR CREATININE (January 7, 1983)

Other clearances for product code DDF

  • K910617 — NATIVE PROTHROMBIN ANTIGEN EIA (May 15, 1991)