The following data is part of a premarket notification filed by Sigma Chemical Co. with the FDA for Cholinesterase Reagent, Dibucaine & Fluoride.
Device ID | K885272 |
510k Number | K885272 |
Device Name: | CHOLINESTERASE REAGENT, DIBUCAINE & FLUORIDE |
Classification | Colorimetry, Cholinesterase |
Applicant | SIGMA CHEMICAL CO. P.O. BOX 14508 St. Louis, MO 63178 |
Contact | Mathew Madappally |
Correspondent | Mathew Madappally SIGMA CHEMICAL CO. P.O. BOX 14508 St. Louis, MO 63178 |
Product Code | DIH |
CFR Regulation Number | 862.3240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-12-22 |
Decision Date | 1989-03-28 |