Product code CIO— Clinical Chemistry
ALKALINE PHOSPHATASE REAGENT SET
- Classification name
- Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes
- Device class
- Class 2
- Regulation
- 21 CFR 862.1050
- Advisory panel
- Clinical Chemistry
- Total cleared
- 11
- First cleared
- Most recent
Market context for product code CIO
FDA has cleared devices under product code CIO between 1977 and 1988, filed by 11 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
- 1988
- 1986
- 1984
- 1983
- 1982
- 1978
- 1977
Top applicants under product code CIO
Recent clearances under product code CIO
- K880177 — ALKALINE PHOSPHATASE, THYMOLPHTHALEIN MONOPHOSPHAT
- K860351 — ALKALINE PHOSPHATASE REAGENT SET
- K855192 — ALKALINE PHOSPHATASE REAGENT SET
- K844498 — SANDARE ALKALINE PHOSPHATASE PROCEDURE
- K844237 — ALKALINE PHOSPHATASE REAGENT SET
- K841064 — ALKALINE PHOSPHOTASE REAGENT SET
- K823578 — COBAS STANDARDS FOR CALCIUM-IN-ORGANIC
- K821200 — ALKALINE PHOSPHOTASE REAGENT SET
- K781324 — ALP TEST
- K772257 — ALKALINE PHOSPHATASE TEST SET
- K770453 — PHOSPHATASE PROCEDURE, TEKPOINT ALKALINE
Data sourced from openFDA. This site is unofficial and independent of the FDA.