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 |