Submission Details
| 510(k) Number | K072141 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 02, 2007 |
| Decision Date | June 24, 2008 |
| Days to Decision | 327 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
S40 CLINICAL ANALYZER, S TEST IP, S TEST UA
Jun 2008
Decision
327d
Days
Class 1
Risk
About This 510(k) Submission
K072141 is an FDA 510(k) clearance for the S40 CLINICAL ANALYZER, S TEST IP, S TEST UA, a Phosphomolybdate (colorimetric), Inorganic Phosphorus (Class I — General Controls, product code CEO), submitted by Alfa Wassermann Diagnostic Technologies, Inc. (West Caldwell, US). The FDA issued a Cleared decision on June 24, 2008, 327 days after receiving the submission on August 2, 2007. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1580.
Device Classification
| Product Code | CEO — Phosphomolybdate (colorimetric), Inorganic Phosphorus |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.1580 |
Manufacturer
Alfa Wassermann Diagnostic Technologies, Inc.
West Caldwell, NJ · US
DAVID SLAVIN
21 submissions
21 cleared
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