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510(k) K863226

ALBUMIN (BCP) by Sigma Diagnostics, Inc. — Product Code CJW

K863226 is an FDA 510(k) premarket notification submitted by Sigma Diagnostics, Inc. for the device "ALBUMIN (BCP)". The FDA issued a decision of Substantially Equivalent on September 17, 1986. The device falls under product code CJW (Bromcresol Purple Dye-Binding, Albumin), a Class II device regulated under 21 CFR 862.1035. Sigma Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 1986
Date Received
August 21, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bromcresol Purple Dye-Binding, Albumin
Device Class
Class II
Regulation Number
862.1035
Review Panel
CH
Submission Type

Other clearances by Sigma Diagnostics, Inc.

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

Other clearances for product code CJW

  • K203530 — Albumin BCP2 (March 18, 2022)
  • K193001 — Albumin BCP (December 19, 2019)
  • K132664 — ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP CALIBRAT (October 16, 2013)
  • K021636 — ALBUMIN REAGENT (July 17, 2002)
  • K000483 — RANDOX ALBUMIN (March 31, 2000)
  • K990978 — ALBUMIN BCG, MODEL AL 103-01 (May 25, 1999)
  • K981814 — ALBP (July 22, 1998)
  • K981457 — ALBP (May 27, 1998)
  • K913025 — ABBOTT QUICKSTART ALBUMIN BCP (ALBP)#5A16 (October 9, 1991)
  • K905776 — ALBUMIN REAGENT SET (February 26, 1991)

FDA data resources