The following data is part of a premarket notification filed by Macherey-nagel-duren with the FDA for Medi-test Combi 11.
| Device ID | K991927 |
| 510k Number | K991927 |
| Device Name: | MEDI-TEST COMBI 11 |
| Classification | Method, Enzymatic, Glucose (urinary, Non-quantitative) |
| Applicant | MACHEREY-NAGEL-DUREN 7475 WISCONSIN ANE SUITE 850 Bethesda, MD 20814 |
| Contact | Eduardo March |
| Correspondent | Eduardo March MACHEREY-NAGEL-DUREN 7475 WISCONSIN ANE SUITE 850 Bethesda, MD 20814 |
| 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 | 1999-06-08 |
| Decision Date | 1999-09-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10763924870100 | K991927 | 000 |