ALKALINE PHOSPHATASE, THYMOLPHTHALEIN MONOPHOSPHAT
FDA 510(k) clearance K880177 · decided 1988-04-05
Clearance details
- K-number
- K880177
- Device name
- ALKALINE PHOSPHATASE, THYMOLPHTHALEIN MONOPHOSPHAT
- Applicant
- Tech-Co, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-01-15
- Decision date
- 1988-04-05
- Days to decision
- 81 days
- Clearance type
- Traditional
- Product code
- CIO
- Device class
- 2
- Regulation number
- 862.1050
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Oak Park, MI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ALKALINE PHOSPHATASE REAGENT SET (K860351) | Sterling Diagnostics, Inc. | 1986-02-11 |
| ALKALINE PHOSPHATASE REAGENT SET (K855192) | Technostics Intl. | 1986-01-14 |
| SANDARE ALKALINE PHOSPHATASE PROCEDURE (K844498) | Sandare Chemical Co., Inc. | 1984-12-10 |
| ALKALINE PHOSPHATASE REAGENT SET (K844237) | Livonia Diagnostics, Inc. | 1984-11-20 |
| ALKALINE PHOSPHOTASE REAGENT SET (K841064) | Medical Specialties, Inc. | 1984-05-01 |
| COBAS STANDARDS FOR CALCIUM-IN-ORGANIC (K823578) | Hoffmann-La Roche, Inc. | 1983-01-07 |
| ALKALINE PHOSPHOTASE REAGENT SET (K821200) | Omega Medical Electronics | 1982-07-13 |
| ALP TEST (K781324) | Analytical & Research Chemicals, Inc. | 1978-08-31 |
| ALKALINE PHOSPHATASE TEST SET (K772257) | Stanbio Laboratory | 1977-12-22 |
| PHOSPHATASE PROCEDURE, TEKPOINT ALKALINE (K770453) | Icn Pharmaceuticals, Inc. | 1977-05-03 |
Recalls involving this device
No recalls on record reference this clearance.