The following data is part of a premarket notification filed by Dass, Inc. with the FDA for Dass Pack.
| Device ID | K851280 |
| 510k Number | K851280 |
| Device Name: | DASS PACK |
| Classification | Diluent, Blood Cell |
| Applicant | DASS, INC. DIAG. ASSOC. SERVICES & SALES 155A NEW BOSTON STREET WOBURN, MA 01801 |
| Contact | FRANK F CALO |
| Correspondent | FRANK F CALO DASS, INC. DIAG. ASSOC. SERVICES & SALES 155A NEW BOSTON STREET WOBURN, MA 01801 |
| Product Code | GIF |
| CFR Regulation Number | 864.8200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-01 |
| Decision Date | 1985-07-05 |