Home / 510(k) Clearances / K990978

510(k) K990978

ALBUMIN BCG, MODEL AL 103-01 by A.P. Total Care, Inc. — Product Code CJW

K990978 is an FDA 510(k) premarket notification submitted by A.P. Total Care, Inc. for the device "ALBUMIN BCG, MODEL AL 103-01". The FDA issued a decision of Substantially Equivalent on May 25, 1999. The device falls under product code CJW (Bromcresol Purple Dye-Binding, Albumin), a Class II device regulated under 21 CFR 862.1035. A.P. Total Care, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 1999
Date Received
March 23, 1999
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 A.P. Total Care, Inc.

  • K991246 — FRUCTOSAMINE, MODEL FR 106-01 (December 16, 1999)
  • K991762 — ALKALINE PHOPHATASE (ALP), PRODUCT NO'S 118-01, 118-02 (September 2, 1999)
  • K991761 — MAGNESIUM PRODUCT NO'S, 112-01, 112-02 (September 2, 1999)
  • K991664 — LDL CHOLESTEROL, PRODUCT NO'S, 124-01, CH102-01 (August 19, 1999)
  • K991665 — HDL CHOLESTEROL, PRODUCT NO'S 124-01, CH102-01 (August 10, 1999)
  • K991866 — BILIRUBIN, TOTAL AND DIRECT, PRODUCT NO, 122-01, 122-02, 122-03, 122-04 (August 2, 1999)
  • K991867 — INORGANIC PHOSPHORUS (IP), PRODUCT NO'S, 112-01, 112-02 (August 2, 1999)
  • K991870 — ELECTROLYTES (NA+, K+, CL-), PRODUCT NO'S 114-01, 114-02, 114-03 (July 30, 1999)
  • K991666 — TIBC, PRODUCT NO'S 123-0, 123-02, FE109-01, FE109-02 (June 30, 1999)
  • K991663 — AST/SGOT (June 30, 1999)

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)
  • 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)
  • K863226 — ALBUMIN (BCP) (September 17, 1986)

FDA data resources