The following data is part of a premarket notification filed by Cenogenics Corp. with the FDA for Chemview-10.
| Device ID | K042641 |
| 510k Number | K042641 |
| Device Name: | CHEMVIEW-10 |
| Classification | Method, Enzymatic, Glucose (urinary, Non-quantitative) |
| Applicant | CENOGENICS CORP. 100 RT. 520 Morganville, NJ 07751 |
| Contact | Nitza Katz |
| Correspondent | Nitza Katz CENOGENICS CORP. 100 RT. 520 Morganville, NJ 07751 |
| Product Code | JIL |
| CFR Regulation Number | 862.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-27 |
| Decision Date | 2005-01-07 |
| Summary: | summary |