The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Accuchek Instant Plus Dual Testing System, Accuchek Instant Plus Cholesterol, Accuchek Instant Plus Glucocose.
| Device ID | K051376 |
| 510k Number | K051376 |
| Device Name: | ACCUCHEK INSTANT PLUS DUAL TESTING SYSTEM, ACCUCHEK INSTANT PLUS CHOLESTEROL, ACCUCHEK INSTANT PLUS GLUCOCOSE |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| Applicant | Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
| Contact | Jennifer Tribbett |
| Correspondent | Jennifer Tribbett Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
| Product Code | CHH |
| Subsequent Product Code | CGA |
| Subsequent Product Code | NBW |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-26 |
| Decision Date | 2005-08-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00365702456105 | K051376 | 000 |
| 00365702284104 | K051376 | 000 |
| 00365702276109 | K051376 | 000 |
| 04015630946365 | K051376 | 000 |