The following data is part of a premarket notification filed by Bayer Diagnostics Corp. with the FDA for Advia 1650 Cholinesterase Assay.
| Device ID | K013750 |
| 510k Number | K013750 |
| Device Name: | ADVIA 1650 CHOLINESTERASE ASSAY |
| Classification | Colorimetry, Cholinesterase |
| Applicant | BAYER DIAGNOSTICS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Contact | Kenneth T Edds |
| Correspondent | Kenneth T Edds BAYER DIAGNOSTICS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Product Code | DIH |
| CFR Regulation Number | 862.3240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-13 |
| Decision Date | 2002-01-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414596273 | K013750 | 000 |
| 00630414510149 | K013750 | 000 |
| 00630414465401 | K013750 | 000 |