S40 CLINICAL ANALYZER, S TEST ALP, S TEST AMYLASE, S TEST AST
FDA 510(k) clearance K072142 · decided 2008-06-26
Clearance details
- K-number
- K072142
- Device name
- S40 CLINICAL ANALYZER, S TEST ALP, S TEST AMYLASE, S TEST AST
- Applicant
- Alfa Wassermann Diagnostic Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-08-02
- Decision date
- 2008-06-26
- Days to decision
- 329 days
- Clearance type
- Traditional
- Product code
- CKF
- Device class
- 2
- Regulation number
- 862.1050
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- West Caldwell, NJ, 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 |
|---|---|---|
| HICHEM ALP/AMP REAGENT KIT (K963383) | Hichem Diagnostics | 1996-09-23 |
Recalls involving this device
No recalls on record reference this clearance.