The following data is part of a premarket notification filed by Hoffmann-la Roche, Inc. with the FDA for Amylochrome Stat Separator, Test.
| Device ID | K790485 |
| 510k Number | K790485 |
| Device Name: | AMYLOCHROME STAT SEPARATOR, TEST |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | HOFFMANN-LA ROCHE, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-03-12 |
| Decision Date | 1979-05-03 |