510(k) K012397 ยท JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
URISYS 2400 URINE TEST STRIP
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Sep 26, 2001 |
| Received | Jul 27, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012397
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 15, 2016 | Roche Diagnostics Operations, Inc. URISYS 2400 Urine Analyzer
Automated Urinalysis System
Product Usage:
The RSD 800 is a computer-controlled stand-alone sorting system for sorting barcoded samples. The system has an online connection Terminated |
JIL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.