Product code CJG— Clinical Chemistry
CLINITEK MICROALBUMIN REAGENT STRIPS
- Classification name
- Tetrabromo-M-Cresolsulfonphthalein, 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 CJG
FDA has cleared device under product code CJG, all in 1997, 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 CJG
Recent clearances under product code CJG
Data sourced from openFDA. This site is unofficial and independent of the FDA.