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510(k) K850936

TOTAL PROTEINS by Dilab, Inc. — Product Code CEK

K850936 is an FDA 510(k) premarket notification submitted by Dilab, Inc. for the device "TOTAL PROTEINS". The FDA issued a decision of Substantially Equivalent on June 25, 1985. The device falls under product code CEK (Biuret (Colorimetric), Total Protein), a Class II device regulated under 21 CFR 862.1635. Dilab, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 1985
Date Received
March 7, 1985
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 Dilab, Inc.

  • K862530 — RAPID AS LATEX (April 21, 1987)
  • K850931 — ALBUMIN (June 26, 1985)
  • K850938 — CHOLESTEROL (June 25, 1985)
  • K850934 — PHOSPHORUS (June 25, 1985)
  • K850932 — CREATININE (June 25, 1985)
  • K850933 — URIC ACID (June 25, 1985)
  • K850937 — UREA (June 10, 1985)
  • K850930 — GLUCOSE (June 10, 1985)
  • K850935 — CHLORIDE (June 10, 1985)
  • K850929 — CALCIUM (June 10, 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)

FDA data resources