The following data is part of a premarket notification filed by Boehringer Mannheim Italia Spa with the FDA for Evatest Strip.
| Device ID | K936013 |
| 510k Number | K936013 |
| Device Name: | EVATEST STRIP |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | BOEHRINGER MANNHEIM ITALIA SPA VIA S. UGUZZONE, 5 I-20126 Milano, Italy, IT |
| Contact | Cleve W Laird |
| Correspondent | Cleve W Laird BOEHRINGER MANNHEIM ITALIA SPA VIA S. UGUZZONE, 5 I-20126 Milano, Italy, IT |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-16 |
| Decision Date | 1994-02-25 |