Product code CJW— Clinical Chemistry
ALBP
- Classification name
- Bromcresol Purple Dye-Binding, Albumin
- Device class
- Class 2
- Regulation
- 21 CFR 862.1035
- Advisory panel
- Clinical Chemistry
- Total cleared
- 18
- First cleared
- Most recent
Market context for product code CJW
FDA has cleared devices under product code CJW between 1983 and 2022, filed by 15 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2022
- 2019
- 2013
- 2002
- 2000
- 1999
- 1998
- 1991
- 1986
- 1985
- 1984
- 1983
Top applicants under product code CJW
Recent clearances under product code CJW
- K203530 — Albumin BCP2
- K193001 — Albumin BCP
- K132664 — ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP CALIBRATOR
- K021636 — ALBUMIN REAGENT
- K000483 — RANDOX ALBUMIN
- K990978 — ALBUMIN BCG, MODEL AL 103-01
- K981814 — ALBP
- K981457 — ALBP
- K913025 — ABBOTT QUICKSTART ALBUMIN BCP (ALBP)#5A16
- K905776 — ALBUMIN REAGENT SET
- K863226 — ALBUMIN (BCP)
- K863004 — EMDS(TM) ALBUMIN TESTPACKS, #67652/95
- K862138 — VISION ALBUMIN
- K860423 — A-GENT LIQUID ALBUMIN
- K844426 — ALBUMIN BCP
- K842847 — WAKO AUTOMATED REAGENTS FOR HITACHI 705
- K832632 — ALBUMIN PROCEDURE BCP
- K830934 — QUANTIMETRIX BROMERESOL PURPLE ALBUMIN
Data sourced from openFDA. This site is unofficial and independent of the FDA.