Cleared Traditional

ALBUMIN BCG, MODEL AL 103-01

K990978 · A.P. Total Care, Inc. · Chemistry
May 1999
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K990978 is an FDA 510(k) clearance for the ALBUMIN BCG, MODEL AL 103-01, a Bromcresol Purple Dye-binding, Albumin (Class II — Special Controls, product code CJW), submitted by A.P. Total Care, Inc. (Bridgeport, US). The FDA issued a Cleared decision on May 25, 1999, 63 days after receiving the submission on March 23, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1035.

Submission Details

510(k) Number K990978 FDA.gov
FDA Decision Cleared SESE
Date Received March 23, 1999
Decision Date May 25, 1999
Days to Decision 63 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CJW — Bromcresol Purple Dye-binding, Albumin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1035

Similar Devices — CJW Bromcresol Purple Dye-binding, Albumin

All 17
Albumin BCP2
K203530 · Abbott Ireland Diagnostics Division · Mar 2022
Albumin BCP
K193001 · SENTINEL CH. SpA · Dec 2019
ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP CALIBRATOR
K132664 · Siemens Healthcare Diagnostics, Inc. · Oct 2013
ALBUMIN REAGENT
K021636 · Intersect Systems, Inc. · Jul 2002
RANDOX ALBUMIN
K000483 · Randox Laboratories, Ltd. · Mar 2000
ALBP
K981814 · Abbott Laboratories · Jul 1998