The following data is part of a premarket notification filed by Sclavo, Inc. with the FDA for Alpha-amylase Test.
| Device ID | K860665 |
| 510k Number | K860665 |
| Device Name: | ALPHA-AMYLASE TEST |
| Classification | Catalytic Methods, Amylase |
| Applicant | SCLAVO, INC. 5 MANSARD COURT Wayne, NJ 07470 |
| Contact | Debra Hofmeister |
| Correspondent | Debra Hofmeister SCLAVO, INC. 5 MANSARD COURT Wayne, NJ 07470 |
| Product Code | JFJ |
| CFR Regulation Number | 862.1070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-24 |
| Decision Date | 1986-04-07 |