Product code CJD— Clinical Chemistry
AMYLASE (KINETIC) REAGENT SET
- Classification name
- Nitrosalicylate Reduction, Amylase
- Device class
- Class 2
- Regulation
- 21 CFR 862.1070
- Advisory panel
- Clinical Chemistry
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code CJD
FDA has cleared device under product code CJD, all in 1996, 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 CJD
Recent clearances under product code CJD
Data sourced from openFDA. This site is unofficial and independent of the FDA.