Product code CKE— Clinical Chemistry
ACID PHOSPHATASE REAGENT SET
- Classification name
- Acid Phosphatase, Thymolphthale Inmonophosphate
- Device class
- Class 2
- Regulation
- 21 CFR 862.1020
- Advisory panel
- Clinical Chemistry
- Total cleared
- 9
- First cleared
- Most recent
Market context for product code CKE
FDA has cleared devices under product code CKE between 1979 and 1992, filed by 9 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
- 1992
- 1988
- 1986
- 1984
- 1982
- 1980
- 1979
Top applicants under product code CKE
Recent clearances under product code CKE
- K914167 — CLINICAL CHEM.ANAL.ACID,PROSTATIC ACID PHOSPHATASE
- K915705 — ACID PHOSPHATASE REAGENT SET
- K873726 — ACID PHOSPHATASE TEST
- K864230 — DIMENSION (TM) CLINICAL CHEMISTRY SYSTEM
- K860476 — ACID PHOSPHATASE REAGENT SET
- K843380 — ACID PHOSPHATASE ASSAY KIT
- K821526 — ACID PHOSPHATASE REAGENT SET
- K800693 — STANBIO PROSTATIC ACID PHOSPHATASE TEST
- K790524 — DATA-ZYME ACIA PHOSPHATASE PROCEDURE
Data sourced from openFDA. This site is unofficial and independent of the FDA.