The following data is part of a premarket notification filed by Heraeus Kulzer, Inc. with the FDA for Cholinesterase Method For Technicon Chem1/technico.
| Device ID | K930208 |
| 510k Number | K930208 |
| Device Name: | CHOLINESTERASE METHOD FOR TECHNICON CHEM1/TECHNICO |
| Classification | Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase |
| Applicant | HERAEUS KULZER, INC. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Contact | Gabriel J Muraca |
| Correspondent | Gabriel J Muraca HERAEUS KULZER, INC. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Product Code | DLI |
| CFR Regulation Number | 862.3240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-15 |
| Decision Date | 1993-04-20 |