S40 Clinical Analyzer, S Test Alp, S Test Amylase, S Test Ast
FDA 510(k) K072142 · Alfa Wassermann Diagnostic Technologies, Inc.
510(k) numberK072142
Submission
- Device name
- S40 Clinical Analyzer, S Test Alp, S Test Amylase, S Test Ast
- Applicant
- Alfa Wassermann Diagnostic Technologies, Inc.
West Caldwell, NJ, US - Received
- August 2, 2007
- Decision date
- June 26, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CKF – Phenylphosphate, Alkaline Phosphatase Or Isoenzymes
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1050
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CKF
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|---|---|---|---|
| K963383 | Hichem Alp/Amp Reagent KitCKF · Traditional | Hichem Diagnostics | 09/23/1996SE |
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Questions and answers
When was S40 Clinical Analyzer, S Test Alp, S Test Amylase, S Test Ast cleared by the FDA?
S40 Clinical Analyzer, S Test Alp, S Test Amylase, S Test Ast (K072142) received a 510(k) decision of Substantially Equivalent on June 26, 2008, 329 days after the submission was received.
What is the product code of K072142?
The FDA product code is CKF – Phenylphosphate, Alkaline Phosphatase Or Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1050.