Home / 510(k) Clearances / K844331

510(k) K844331

TOTAL PROTEIN REAGENT FOR DEMAND ANALYZER by Advanced Biomedical Methods, Inc. — Product Code CEK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 1985
Date Received
November 7, 1984
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 Advanced Biomedical Methods, Inc.

  • K945353 — CLARIT(TM) (December 9, 1994)
  • K880949 — SINGLE REAGENT CALCIUM FOR DEMAND ANALYZER (April 5, 1988)
  • K864866 — RESUBMISSION OF THE KLEERZIT REAGENT (March 16, 1987)
  • K852784 — ALKALINE PHOSPHATASE (July 22, 1985)
  • K852783 — SGOT/ALT REAGENT (July 22, 1985)
  • K852027 — GGTP REAGENT/SERUM IRON/SALICYLATE DEMAND ANALYZER (May 29, 1985)
  • K850378 — LDH REAGENT FOR DEMAND ANALYZER (March 1, 1985)
  • K850380 — INORGANIC PHOSPHOROUS FOR DEMAND ANALYZER (March 1, 1985)
  • K850379 — DIRECT BILIRUBIN FOR DEMAND ANALYZER (March 1, 1985)
  • K850381 — MAGNESIUM REAGENT FOR DEMAND ANALYZER (March 1, 1985)

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)