The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Chemstrip 5 Ob, Chemstrip 7 And Chemstrip 10 Md Test Strips.
| Device ID | K032437 |
| 510k Number | K032437 |
| Device Name: | CHEMSTRIP 5 OB, CHEMSTRIP 7 AND CHEMSTRIP 10 MD TEST STRIPS |
| Classification | Method, Enzymatic, Glucose (urinary, Non-quantitative) |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. PO BX 50457 Indianapolis, IN 46250 -0457 |
| Contact | Jennifer Tribbett |
| Correspondent | Jennifer Tribbett ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. PO BX 50457 Indianapolis, IN 46250 -0457 |
| Product Code | JIL |
| Subsequent Product Code | CDM |
| Subsequent Product Code | CEN |
| Subsequent Product Code | JIN |
| Subsequent Product Code | JIO |
| Subsequent Product Code | JIR |
| Subsequent Product Code | JJB |
| Subsequent Product Code | JMT |
| Subsequent Product Code | JRE |
| Subsequent Product Code | LJX |
| CFR Regulation Number | 862.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-07 |
| Decision Date | 2003-10-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00075537671603 | K032437 | 000 |
| 00075537313121 | K032437 | 000 |
| 00075537018934 | K032437 | 000 |