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510(k) K823579

COBAS REAGENT FOR TOTAL PROTEIN by Hoffmann-La Roche, Inc. — Product Code CEK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 1983
Date Received
December 6, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Biuret (Colorimetric), Total Protein
Device Class
Class II
Regulation Number
862.1635
Review Panel
CH
Submission Type

Other clearances by Hoffmann-La Roche, Inc.

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  • K830462 — ABUSCREEN RADIOUMMUNOASSAY--URINE (March 24, 1983)
  • K830482 — ABUSCREEN RADIOIMMUNOASSAY-AMPHETAMINE (March 24, 1983)
  • K830481 — ABUSCREEN RADIOIMMUNOASSAY-PHENCYCLIDINE (March 24, 1983)
  • K830460 — ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE (March 24, 1983)
  • K830480 — ABUSCREEN RADIOIMMUNOASSAY-COCAINE META (March 24, 1983)
  • K830479 — ABUSCREEN RADIOIMMUNOASSAY-BARBITURATE (March 10, 1983)
  • K823578 — COBAS STANDARDS FOR CALCIUM-IN-ORGANIC (January 7, 1983)

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  • K980042 — CARESIDE TOTAL PROTEIN (February 4, 1998)
  • K971524 — TOTAL PROTEIN OR TP (May 16, 1997)
  • K961864 — CSF/URINE TOTAL PROTEIN (October 24, 1996)
  • K955905 — STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAY (May 30, 1996)
  • K955936 — TOTAL PROTEIN REAGENT (March 12, 1996)
  • K950920 — DUPONT DIMENSION TOTAL PROTEIN METHOD (August 11, 1995)
  • K950234 — TOTAL PROTEIN TEST (TPRO) ITEM NUMBER: XXXXX/R1. R2 (June 14, 1995)
  • K950128 — TOTAL PROTEIN TEST (TPRO) ITEM XXXXX/R1. R2 (May 15, 1995)