The following data is part of a premarket notification filed by Sclavo, Inc. with the FDA for Acp Kinetic Test (acid Phosphatase Test).
| Device ID | K881204 |
| 510k Number | K881204 |
| Device Name: | ACP KINETIC TEST (ACID PHOSPHATASE TEST) |
| Classification | Acid Phosphatase, Naphthyl Phosphate |
| Applicant | SCLAVO, INC. 5 MANSARD COURT Wayne, NJ 07470 |
| Contact | King, Phd |
| Correspondent | King, Phd SCLAVO, INC. 5 MANSARD COURT Wayne, NJ 07470 |
| Product Code | CKB |
| CFR Regulation Number | 862.1020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-21 |
| Decision Date | 1988-04-28 |