The following data is part of a premarket notification filed by Molecular Diagnostics with the FDA for Inpath E2 Collector.
| Device ID | K013258 |
| 510k Number | K013258 |
| Device Name: | INPATH E2 COLLECTOR |
| Classification | Spatula, Cervical, Cytological |
| Applicant | MOLECULAR DIAGNOSTICS 414 N. ORLEANS SUITE 510 Chicago, IL 60610 |
| Contact | Robert L Habig |
| Correspondent | Robert L Habig MOLECULAR DIAGNOSTICS 414 N. ORLEANS SUITE 510 Chicago, IL 60610 |
| Product Code | HHT |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-01 |
| Decision Date | 2002-05-31 |
| Summary: | summary |