The following data is part of a premarket notification filed by Crestat Diagnostics, Inc. with the FDA for Cholinesterase Test Kit.
| Device ID | K912148 |
| 510k Number | K912148 |
| Device Name: | CHOLINESTERASE TEST KIT |
| Classification | Colorimetry, Cholinesterase |
| Applicant | CRESTAT DIAGNOSTICS, INC. 22750 HAWTHORNE BLVD., SUITE 206 Torrance, CA 90505 |
| Contact | Mike Mukai |
| Correspondent | Mike Mukai CRESTAT DIAGNOSTICS, INC. 22750 HAWTHORNE BLVD., SUITE 206 Torrance, CA 90505 |
| Product Code | DIH |
| CFR Regulation Number | 862.3240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-15 |
| Decision Date | 1991-08-12 |