Submission Details
| 510(k) Number | K122177 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 23, 2012 |
| Decision Date | February 15, 2013 |
| Days to Decision | 207 days |
| Submission Type | Abbreviated |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Abbreviated
ELITECH CLINICAL SYSTEMS URINE TOTAL PROTEIN PLUS STANDARD 100 MG/DL, ELITECH CLINICAL SYSTEMS URINE CONTROL BI-LEVEL
Feb 2013
Decision
207d
Days
Class 2
Risk
About This 510(k) Submission
K122177 is an FDA 510(k) clearance for the ELITECH CLINICAL SYSTEMS URINE TOTAL PROTEIN PLUS STANDARD 100 MG/DL, ELITECH CLINICAL SYSTEMS URINE CONTROL BI-LEVEL, a Calibrator, Secondary (Class II — Special Controls, product code JIT), submitted by Elitechgroup (Bothell, US). The FDA issued a Cleared decision on February 15, 2013, 207 days after receiving the submission on July 23, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.
Device Classification
| Product Code | JIT — Calibrator, Secondary |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1150 |
Manufacturer
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