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510(k) K935174

TOTAL PROTEIN TEST (TPRO) by Em Diagnostic Systems, Inc. — Product Code CEK

K935174 is an FDA 510(k) premarket notification submitted by Em Diagnostic Systems, Inc. for the device "TOTAL PROTEIN TEST (TPRO)". The FDA issued a decision of Substantially Equivalent on December 16, 1993. The device falls under product code CEK (Biuret (Colorimetric), Total Protein), a Class II device regulated under 21 CFR 862.1635. Em Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 1993
Date Received
October 27, 1993
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 Em Diagnostic Systems, Inc.

  • K935181 — ASPARTATE AMINOTRANSFERASE (AST) TEST (January 27, 1994)
  • K935180 — ALANINE AMINOTRANSFERASE (ALT) TEST (January 13, 1994)
  • K935178 — EMDS PHOSPHOROUS (PHOS) TEST (December 17, 1993)
  • K935179 — EMDS ALBUMIN (ALB) TEST (December 17, 1993)
  • K935136 — CHOLESTEROL (CHOL) TEST ITEM NO. 65410 (December 16, 1993)
  • K935176 — IRON TEST (December 16, 1993)
  • K935177 — GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST (December 16, 1993)
  • K935175 — LACTATE DEHYDROGENASE (LD) (December 16, 1993)
  • K935183 — EMDS MAGNESIUM (MG) TEST (December 9, 1993)
  • K935182 — EMDS ALKANINE PHOSPHATASE (ALP) TEST (December 9, 1993)

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