The following data is part of a premarket notification filed by Schiapparelli Biosystems, Inc. with the FDA for Ace Amylase Reagent.
| Device ID | K951548 |
| 510k Number | K951548 |
| Device Name: | ACE AMYLASE REAGENT |
| Classification | Catalytic Methods, Amylase |
| Applicant | SCHIAPPARELLI BIOSYSTEMS, INC. 9033 RED BRANCH RD. Columbia, MD 21045 |
| Contact | Mark A Spain |
| Correspondent | Mark A Spain SCHIAPPARELLI BIOSYSTEMS, INC. 9033 RED BRANCH RD. Columbia, MD 21045 |
| Product Code | JFJ |
| CFR Regulation Number | 862.1070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-04 |
| Decision Date | 1995-05-15 |