The following data is part of a premarket notification filed by Sclavo, Inc. with the FDA for Atypical Cholinesterase.
Device ID | K873496 |
510k Number | K873496 |
Device Name: | ATYPICAL CHOLINESTERASE |
Classification | Colorimetry, Cholinesterase |
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 | DIH |
CFR Regulation Number | 862.3240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-08-18 |
Decision Date | 1989-01-27 |