P/N 35310, IL TEST ALKALINE PHOSPHATASE REAGENT
FDA 510(k) clearance K904761 · decided 1990-11-20
Clearance details
- K-number
- K904761
- Device name
- P/N 35310, IL TEST ALKALINE PHOSPHATASE REAGENT
- Applicant
- Instrumentation Laboratory CO
- Decision
- Substantially Equivalent
- Date received
- 1990-10-19
- Decision date
- 1990-11-20
- Days to decision
- 32 days
- Clearance type
- Traditional
- Product code
- CIE
- Device class
- 2
- Regulation number
- 862.1160
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Lexington, MA, 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 |
|---|---|---|
| MICRO CO2 APPARATUS (K880967) | Hf Scientific, Inc. | 1988-04-28 |
| CO2 REAGENT SET (K864313) | Hf Scientific, Inc. | 1987-03-13 |
| TOTAL CO2 REAGENT SET (K832071) | American Research Products Co. | 1983-08-11 |
| AIRMED SMOKE EVACUATION & FILTER (K820091) | James L. Geraci & Associates, Inc. | 1982-02-24 |
| SERALYZER REFLECTANCE PHOTOMETER/CALIB. (K800524) | Miles Laboratories, Inc. | 1980-04-02 |
| CARBON DIOXIDE ANALYZER (K771610) | Corning Medical & Scientific | 1977-10-07 |
Recalls involving this device
No recalls on record reference this clearance.