Product code CJF— Clinical Chemistry

FLOW-PAC ALKALINE PHOSPHATE REAGENT SET

Classification name
Tetrabromophenolphthalein, Albumin
Device class
Class 2
Regulation
21 CFR 862.1035
Advisory panel
Clinical Chemistry
Total cleared
1
First cleared
Most recent

Market context for product code CJF

FDA has cleared 1 device under product code CJF, all in 1983, filed by 1 applicant company. 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.

Top applicants under product code CJF

Recent clearances under product code CJF

Data sourced from openFDA. This site is unofficial and independent of the FDA.