The following data is part of a premarket notification filed by Wellcome Diagnostics with the FDA for Streptex Zl01.
| Device ID | K842828 |
| 510k Number | K842828 |
| Device Name: | STREPTEX ZL01 |
| Classification | Discs, Strips And Reagents, Microorganism Differentiation |
| Applicant | WELLCOME DIAGNOSTICS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JTO |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-20 |
| Decision Date | 1984-08-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05056080501475 | K842828 | 000 |
| 05056080501383 | K842828 | 000 |
| 05056080501390 | K842828 | 000 |
| 05056080501406 | K842828 | 000 |
| 05056080501413 | K842828 | 000 |
| 05056080501420 | K842828 | 000 |
| 05056080501437 | K842828 | 000 |
| 05056080501444 | K842828 | 000 |
| 05056080501451 | K842828 | 000 |
| 05056080501468 | K842828 | 000 |
| 05056080501376 | K842828 | 000 |