The following data is part of a premarket notification filed by Bayer Healthcare, Llc with the FDA for Clinitek Advantus, Model 1420.
| Device ID | K063276 |
| 510k Number | K063276 |
| Device Name: | CLINITEK ADVANTUS, MODEL 1420 |
| Classification | Method, Enzymatic, Glucose (urinary, Non-quantitative) |
| Applicant | BAYER HEALTHCARE, LLC 2 EDGEWATER DR. Norwood, MA 02062 -4658 |
| Contact | Noor Malki |
| Correspondent | Noor Malki BAYER HEALTHCARE, LLC 2 EDGEWATER DR. Norwood, MA 02062 -4658 |
| Product Code | JIL |
| Subsequent Product Code | CDM |
| Subsequent Product Code | CEN |
| Subsequent Product Code | JFY |
| 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 | KQO |
| Subsequent Product Code | LJX |
| CFR Regulation Number | 862.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-30 |
| Decision Date | 2006-12-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414593562 | K063276 | 000 |