510(k) K072142
- Device
- S40 CLINICAL ANALYZER, S TEST ALP, S TEST AMYLASE, S TEST AST
- Applicant
- ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC.
- 510(k) number
- K072142
- Product code
- CKF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-06-26
- Date received
- 2007-08-02
- Regulation
- 862.1050
- Classification name
- Phenylphosphate, Alkaline Phosphatase Or Isoenzymes
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAVID SLAVIN
- Address
- 4 Henderson Dr. West Caldwell NJ US 07006 07006
FDA Registration Numbers#
- 3021841051
- 2939693
Source Documents#
Other 510(k) Records For Product Code CKF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K963383 | HICHEM ALP/AMP REAGENT KIT | Hichem Diagnostics | 1996-09-23 |
Legacy Summary#
summary
FDA Review#
Decision Summary