The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Cholinesterase Gen.2 Test System.
| Device ID | K061093 |
| 510k Number | K061093 |
| Device Name: | CHOLINESTERASE GEN.2 TEST SYSTEM |
| Classification | Colorimetry, Cholinesterase |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Contact | Theresa M Ambrose |
| Correspondent | Theresa M Ambrose ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Product Code | DIH |
| CFR Regulation Number | 862.3240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-19 |
| Decision Date | 2006-07-03 |
| Summary: | summary |