Product code CJO— Clinical Chemistry
ALKALINE PHOSPHATASE ISOYZME REAGENT SET
- Classification name
- Alpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes
- Device class
- Class 2
- Regulation
- 21 CFR 862.1050
- Advisory panel
- Clinical Chemistry
- Total cleared
- 4
- First cleared
- Most recent
Market context for product code CJO
FDA has cleared devices under product code CJO between 1977 and 2012, filed by 3 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
- 2012
- 1999
- 1977
Top applicants under product code CJO
Recent clearances under product code CJO
- K122323 — DIMENSION VISTA ALKALINE PHOSPHATASE (ALPI) FLEX REAGENT CARTRIDGE DIMENSION VISTA ALKALINE PHOSPHATASE CALIBRATOR (ALPI
- K121907 — DIMENSION ALKALINE PHOSPHATASE FLEX REAGENT CARTRIDGE, DIMENSION ALKALINE PHOSPHATASE CALIBRATOR
- K982328 — BAYER ADVIA IMS SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
- K770155 — ALKALINE PHOSPHATASE ISOYZME REAGENT SET
Data sourced from openFDA. This site is unofficial and independent of the FDA.