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510(k) K812833

TOTAL PROTEIN REAGENT SET by Anco Medical Reagents & Assoc. — Product Code CEK

K812833 is an FDA 510(k) premarket notification submitted by Anco Medical Reagents & Assoc. for the device "TOTAL PROTEIN REAGENT SET". The FDA issued a decision of Substantially Equivalent on November 27, 1981. The device falls under product code CEK (Biuret (Colorimetric), Total Protein), a Class II device regulated under 21 CFR 862.1635. Anco Medical Reagents & Assoc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 1981
Date Received
October 9, 1981
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 Anco Medical Reagents & Assoc.

  • K842440 — SICKLE CELL STAT A/S HETEROZYGOUS-ERYTH (July 27, 1984)
  • K831871 — SICKLE-HEME A/S CONTROLS & A/A CONTROL (July 28, 1983)
  • K821658 — HEMOGLOBIN REAGENT (June 25, 1982)
  • K821526 — ACID PHOSPHATASE REAGENT SET (June 10, 1982)
  • K821102 — MEGNESIUM REAGENT KIT (May 5, 1982)
  • K820951 — ENZYMATIC CHOLESTEROL KIT (April 26, 1982)
  • K820466 — SGOT REAGENT SET (March 11, 1982)
  • K820491 — SGPT REAGENT SET (March 11, 1982)
  • K820500 — TOTAL LIPID REAGENT SET (March 11, 1982)
  • K812837 — ALKALINE PHOSPHATASE REAGENT SET (January 29, 1982)

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