Submission Details
| 510(k) Number | K100263 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 28, 2010 |
| Decision Date | May 06, 2011 |
| Days to Decision | 463 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTS
May 2011
Decision
463d
Days
Class 1
Risk
About This 510(k) Submission
K100263 is an FDA 510(k) clearance for the ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTS, a Phosphomolybdate (colorimetric), Inorganic Phosphorus (Class I — General Controls, product code CEO), submitted by Seppim S.A.S. (Bothell, US). The FDA issued a Cleared decision on May 6, 2011, 463 days after receiving the submission on January 28, 2010. 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
Similar Devices — CEO Phosphomolybdate (colorimetric), Inorganic Phosphorus
All 104
K072141 · Alfa Wassermann Diagnostic Technologies, Inc.
· Jun 2008
K041643 · Beckman Coulter, Inc.
· Aug 2004
K030015 · Elan Diagnostics
· Mar 2003
K022312 · Abaxis, Inc.
· Sep 2002
K013095 · Wiener Laboratories Saic
· Nov 2001
K003912 · Jas Diagnostics, Inc.
· Feb 2001
More from Seppim S.A.S.
View all
K103376
· JFY · Nov 2011
K100547
· LCP · May 2011
K102993
· CDT · May 2011
K100525
· CGA · Dec 2010
K093883
· CIT · Sep 2010