The following data is part of a premarket notification filed by Scientific Distributors, Inc. with the FDA for Sdi Prepax Dilukit M..
| Device ID | K851320 |
| 510k Number | K851320 |
| Device Name: | SDI PREPAX DILUKIT M. |
| Classification | Diluent, Blood Cell |
| Applicant | SCIENTIFIC DISTRIBUTORS, INC. BLDG 24 ENDICOTT ST. Norwood, MA 02062 |
| Contact | Michael J Boyle |
| Correspondent | Michael J Boyle SCIENTIFIC DISTRIBUTORS, INC. BLDG 24 ENDICOTT ST. Norwood, MA 02062 |
| Product Code | GIF |
| CFR Regulation Number | 864.8200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-02 |
| Decision Date | 1985-07-05 |