Product code CJR— Clinical Chemistry

SANDARE ACID PHOSPHATASE PROCEDURE

Classification name
Acid Phosphatase, Thymol Blue Monophosphate
Device class
Class 2
Regulation
21 CFR 862.1020
Advisory panel
Clinical Chemistry
Total cleared
2
First cleared
Most recent

Market context for product code CJR

FDA has cleared 2 devices under product code CJR between 1976 and 1984, filed by 2 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

Top applicants under product code CJR

Recent clearances under product code CJR

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