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510(k) K905790

TOTAL PROTEIN REAGENT SET by Biochemical Trade, Inc. — Product Code CEK

K905790 is an FDA 510(k) premarket notification submitted by Biochemical Trade, Inc. for the device "TOTAL PROTEIN REAGENT SET". The FDA issued a decision of Substantially Equivalent on February 21, 1991. The device falls under product code CEK (Biuret (Colorimetric), Total Protein), a Class II device regulated under 21 CFR 862.1635. Biochemical Trade, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 1991
Date Received
December 27, 1990
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 Biochemical Trade, Inc.

  • K942958 — CREATINE KINASE MB DETERMINATION (UV) (November 21, 1994)
  • K910635 — TOTAL BILIRUBIN REAGENT SET (May 15, 1991)
  • K910296 — PHOSPHORUS (INORGANIC) TEST SYSTEM (February 27, 1991)
  • K905776 — ALBUMIN REAGENT SET (February 26, 1991)
  • K905650 — KINETIC ALKALINE PHOSPHATASE DETERMINATION (February 13, 1991)
  • K905619 — CREATININE (RATE) REAGENT SET (February 13, 1991)
  • K905651 — KINETIC AMYLASE DETERMINATION (January 31, 1991)
  • K905649 — GAMMA-GLUTAMYL TRANSFERASE DETERMINATION (January 30, 1991)
  • K905588 — CREATINE KINASE UV REAGENT SET (January 17, 1991)
  • K871547 — ULTRA-VIOLET BUN REAGENT KIT (RATE) (June 22, 1987)

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)
  • 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)

FDA data resources