510(k) K963383
- Device
- HICHEM ALP/AMP REAGENT KIT
- Applicant
- HICHEM DIAGNOSTICS
- 510(k) number
- K963383
- Product code
- CKF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-09-23
- Date received
- 1996-08-27
- 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
- WYNN STOCKING
- Address
- 231 N. Puente St. Brea CA US 92821 92821
FDA Registration Numbers#
- 2939693
- 3021841051
Source Documents#
Other 510(k) Records For Product Code CKF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K072142 | S40 CLINICAL ANALYZER, S TEST ALP, S TEST AMYLASE, S TEST AST | Alfa Wassermann Diagnostic Technologies, Inc. | 2008-06-26 |
Legacy Summary#
summary
FDA Review#
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