510(k) K770453
- Device
- PHOSPHATASE PROCEDURE, TEKPOINT ALKALINE
- Applicant
- Icn Pharmaceuticals, Inc.
- 510(k) number
- K770453
- Product code
- CIO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-05-03
- Date received
- 1977-03-08
- Regulation
- 862.1050
- Classification name
- Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 13 Mountainview Ave. Orangeburg NY US 10962 10962
FDA Registration Numbers#
- 1832216
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code CIO#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K880177 | ALKALINE PHOSPHATASE, THYMOLPHTHALEIN MONOPHOSPHAT | Tech-Co, Inc. | 1988-04-05 |
| K860351 | ALKALINE PHOSPHATASE REAGENT SET | Sterling Diagnostics, Inc. | 1986-02-11 |
| K855192 | ALKALINE PHOSPHATASE REAGENT SET | Technostics Intl. | 1986-01-14 |
| K844498 | SANDARE ALKALINE PHOSPHATASE PROCEDURE | Sandare Chemical Co., Inc. | 1984-12-10 |
| K844237 | ALKALINE PHOSPHATASE REAGENT SET | Livonia Diagnostics, Inc. | 1984-11-20 |
| K841064 | ALKALINE PHOSPHOTASE REAGENT SET | Medical Specialties, Inc. | 1984-05-01 |
| K823578 | COBAS STANDARDS FOR CALCIUM-IN-ORGANIC | Hoffmann-La Roche, Inc. | 1983-01-07 |
| K821200 | ALKALINE PHOSPHOTASE REAGENT SET | Omega Medical Electronics | 1982-07-13 |
| K781324 | ALP TEST | Analytical & Research Chemicals, Inc. | 1978-08-31 |
| K772257 | ALKALINE PHOSPHATASE TEST SET | Stanbio Laboratory | 1977-12-22 |