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510(k) K955936

TOTAL PROTEIN REAGENT by Derma Media Lab., Inc. — Product Code CEK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 1996
Date Received
December 21, 1995
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 Derma Media Lab., Inc.

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  • K971005 — TRIGLYCERIDES (April 21, 1997)
  • K970867 — URIC ACID REAGENT (April 21, 1997)
  • K964915 — MAGNESIUM (March 26, 1997)
  • K964913 — IRON REAGENT (February 20, 1997)
  • K965134 — ALT/SGPT (February 18, 1997)
  • K964914 — ALKALINE PHOSPHATASE (February 4, 1997)
  • K965126 — AST/SGOT (January 17, 1997)

Other clearances for product code CEK

  • K992846 — HICHEM TOTAL PROTEIN REAGENT (October 18, 1999)
  • K973108 — TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50 (March 2, 1998)
  • 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)
  • 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)
  • K943004 — TOTAL PROTEIN QVET (December 9, 1994)