The following data is part of a premarket notification filed by Boehringer Mannheim Italia Spa with the FDA for Accustat Hcg Serum Diluent Reagent Or Event Serum Diluent.
| Device ID | K955266 |
| 510k Number | K955266 |
| Device Name: | ACCUSTAT HCG SERUM DILUENT REAGENT OR EVENT SERUM DILUENT |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | BOEHRINGER MANNHEIM ITALIA SPA 1420 LOS ANGELES AVE. SUITE 201 Simi Valley, CA 93065 |
| Contact | Cleve W Lair |
| Correspondent | Cleve W Lair BOEHRINGER MANNHEIM ITALIA SPA 1420 LOS ANGELES AVE. SUITE 201 Simi Valley, CA 93065 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-15 |
| Decision Date | 1996-02-29 |