The following data is part of a premarket notification filed by Sclavo, Inc. with the FDA for Cholinesterase - Butyrythiocholine Substrate.
| Device ID | K880049 |
| 510k Number | K880049 |
| Device Name: | CHOLINESTERASE - BUTYRYTHIOCHOLINE SUBSTRATE |
| Classification | Colorimetry, Cholinesterase |
| 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 | DIH |
| CFR Regulation Number | 862.3240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-06 |
| Decision Date | 1989-01-27 |