FDA Product Code CJW: Bromcresol Purple Dye-binding, Albumin
Leading manufacturers include Abbott Laboratories, Em Diagnostic Systems, Inc. and Siemens Healthcare Diagnostics, Inc..
18
Total
18
Cleared
76d
Avg days
1983
Since
Stable submission activity - 0 submissions in the last 2 years
FDA 510(k) Cleared Bromcresol Purple Dye-binding, Albumin Devices (Product Code CJW)
18 devices
Cleared
Mar 18, 2022
Albumin BCP2
Abbott Ireland Diagnostics Division
Chemistry
471d
Cleared
Dec 19, 2019
Albumin BCP
SENTINEL CH. SpA
Chemistry
52d
Cleared
Oct 16, 2013
ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP CALIBRATOR
Siemens Healthcare Diagnostics, Inc.
Chemistry
50d
Cleared
Jul 17, 2002
ALBUMIN REAGENT
Intersect Systems, Inc.
Chemistry
61d
Cleared
Mar 31, 2000
RANDOX ALBUMIN
Randox Laboratories, Ltd.
Chemistry
46d
Cleared
May 25, 1999
ALBUMIN BCG, MODEL AL 103-01
A.P. Total Care, Inc.
Chemistry
63d
Cleared
Jul 22, 1998
ALBP
Abbott Laboratories
Chemistry
61d
Cleared
May 27, 1998
ALBP
Abbott Mfg., Inc.
Chemistry
34d
Cleared
Oct 09, 1991
ABBOTT QUICKSTART ALBUMIN BCP (ALBP)#5A16
Em Diagnostic Systems, Inc.
Chemistry
92d
Cleared
Feb 26, 1991
ALBUMIN REAGENT SET
Biochemical Trade, Inc.
Toxicology
61d
Cleared
Sep 17, 1986
ALBUMIN (BCP)
Sigma Diagnostics, Inc.
Chemistry
27d
Cleared
Sep 16, 1986
EMDS(TM) ALBUMIN TESTPACKS, #67652/95
Em Diagnostic Systems, Inc.
Chemistry
39d
Cleared
Jun 17, 1986
VISION ALBUMIN
Abbott Laboratories
Chemistry
13d
Cleared
Mar 17, 1986
A-GENT LIQUID ALBUMIN
Abbott Laboratories
Chemistry
41d
Cleared
Jan 07, 1985
ALBUMIN BCP
Boehringer Mannheim Corp.
Immunology
53d
Cleared
Dec 11, 1984
WAKO AUTOMATED REAGENTS FOR HITACHI 705
Wako Chemicals USA, Inc.
Hematology
144d
Cleared
Sep 12, 1983
ALBUMIN PROCEDURE BCP
Sandare Chemical Co., Inc.
Chemistry
39d
Cleared
Apr 18, 1983
QUANTIMETRIX BROMERESOL PURPLE ALBUMIN
Quantimetrix Corp.
Immunology
26d
About Product Code CJW - Regulatory Context
510(k) Submission Activity
18 total 510(k) submissions under product code CJW since 1983, with 18 receiving FDA clearance (average review time: 76 days).
Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.