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510(k) K832632

ALBUMIN PROCEDURE BCP by Sandare Chemical Co., Inc. — Product Code CJW

K832632 is an FDA 510(k) premarket notification submitted by Sandare Chemical Co., Inc. for the device "ALBUMIN PROCEDURE BCP". The FDA issued a decision of Substantially Equivalent on September 12, 1983. The device falls under product code CJW (Bromcresol Purple Dye-Binding, Albumin), a Class II device regulated under 21 CFR 862.1035. Sandare Chemical Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1983
Date Received
August 4, 1983
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 Sandare Chemical Co., Inc.

  • K872852 — EAGLE DIAGNOSTICS GLYCOHEMOGLOBIN UNITIZED TEST (September 29, 1987)
  • K862556 — SANDARE GLYCOHEMOGLOBIN PROCEDURE (August 8, 1986)
  • K860684 — SANDARE BCG ALBUMIN PROCEDURE (March 17, 1986)
  • K851395 — SANDARE IRON-BINDING CAPACITY PROCEDURE (May 7, 1985)
  • K851394 — SANDARE IRON PROCEDURE (April 30, 1985)
  • K844498 — SANDARE ALKALINE PHOSPHATASE PROCEDURE (December 10, 1984)
  • K842516 — SANDARE ACID PHOSPHATASE PROCEDURE (August 17, 1984)
  • K833898 — TRI-LEVEL BILIRUBIN CONTROLS (January 13, 1984)
  • K832942 — TOTAL & DIRECT BILIRUBIN PROCEDURES (November 7, 1983)
  • K832183 — SANDARE CALCIUM PROCEDURE (August 24, 1983)

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