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510(k) K915380

MICROPROTEIN-PR by Sigma Diagnostics, Inc. — Product Code CEK

K915380 is an FDA 510(k) premarket notification submitted by Sigma Diagnostics, Inc. for the device "MICROPROTEIN-PR". The FDA issued a decision of Substantially Equivalent on Feb 18, 1992. The device falls under product code CEK (Biuret (Colorimetric), Total Protein), a Class II device regulated under 21 CFR 862.1635. Sigma Diagnostics, Inc. has 163 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Feb 18, 1992
Date Received
Nov 29, 1991
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
510(k) Exempt

Other clearances by Sigma Diagnostics, Inc.

  • K021162 — AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX… (Aug 30, 2002)
  • K020109 — SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL (Feb 6, 2002)
  • K013549 — SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971 (Dec 26, 2001)
  • K013545 — SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221 (Nov 15, 2001)
  • K013544 — SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096 (Nov 15, 2001)
  • K012410 — INFINITY HBA KIT, MODELS 537-A, 537-B (Oct 26, 2001)
  • K010652 — SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936 (Mar 30, 2001)
  • K010158 — THROMBOMAX-HS WITH CALCIUM, MODEL T6540 (Mar 22, 2001)
  • K003267 — SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A (Mar 15, 2001)
  • K003328 — ACCUCLOT CONTROL I, MODEL A4089 (Mar 1, 2001)

Other clearances for product code CEK

  • K992846 — HICHEM TOTAL PROTEIN REAGENT (Oct 18, 1999)
  • K973108 — TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50 (Mar 2, 1998)
  • K980042 — CARESIDE TOTAL PROTEIN (Feb 4, 1998)
  • K971524 — TOTAL PROTEIN OR TP (May 16, 1997)
  • K961864 — CSF/URINE TOTAL PROTEIN (Oct 24, 1996)
  • K955905 — STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAY (May 30, 1996)
  • K955936 — TOTAL PROTEIN REAGENT (Mar 12, 1996)
  • K950920 — DUPONT DIMENSION TOTAL PROTEIN METHOD (Aug 11, 1995)
  • K950234 — TOTAL PROTEIN TEST (TPRO) ITEM NUMBER: XXXXX/R1. R2 (Jun 14, 1995)
  • K950128 — TOTAL PROTEIN TEST (TPRO) ITEM XXXXX/R1. R2 (May 15, 1995)

FDA data resources

Source: FDA 510(k) database entry for K915380. Report a data issue: hello@regdatalab.com.