CIO — Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes Class II
FDA product code CIO covers "Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes", a Class II medical device regulated under 21 CFR 862.1050. Submissions are reviewed by the Clinical Chemistry panel. At least 11 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- CIO
- Device Class
- Class II
- Regulation Number
- 862.1050
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K880177 | tech-co | ALKALINE PHOSPHATASE, THYMOLPHTHALEIN MONOPHOSPHAT | April 5, 1988 |
| K860351 | sterling diagnostics | ALKALINE PHOSPHATASE REAGENT SET | February 11, 1986 |
| K855192 | technostics intl | ALKALINE PHOSPHATASE REAGENT SET | January 14, 1986 |
| K844498 | sandare chemical co | SANDARE ALKALINE PHOSPHATASE PROCEDURE | December 10, 1984 |
| K844237 | livonia diagnostics | ALKALINE PHOSPHATASE REAGENT SET | November 20, 1984 |
| K841064 | medical specialties | ALKALINE PHOSPHOTASE REAGENT SET | May 1, 1984 |
| K823578 | hoffmann-la roche | COBAS STANDARDS FOR CALCIUM-IN-ORGANIC | January 7, 1983 |
| K821200 | omega medical electronics | ALKALINE PHOSPHOTASE REAGENT SET | July 13, 1982 |
| K781324 | analytical and research chemicals | ALP TEST | August 31, 1978 |
| K772257 | stanbio laboratory | ALKALINE PHOSPHATASE TEST SET | December 22, 1977 |
| K770453 | icn pharmaceuticals | PHOSPHATASE PROCEDURE, TEKPOINT ALKALINE | May 3, 1977 |