510(k) K855192
- Device
- ALKALINE PHOSPHATASE REAGENT SET
- Applicant
- TECHNOSTICS INTL.
- 510(k) number
- K855192
- Product code
- CIO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-01-14
- Date received
- 1985-12-26
- 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
- No
Applicant Contact#
- Contact
- SUSAN RENEHAN
- Address
- P.O. Box 94090 Washington MI US 48094 48094
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 |
| 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 |
| K770453 | PHOSPHATASE PROCEDURE, TEKPOINT ALKALINE | Icn Pharmaceuticals, Inc. | 1977-05-03 |
Legacy Summary#
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FDA Review#
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