The following data is part of a premarket notification filed by Cenogenics Corp. with the FDA for Accunate-one Step, Accunate-one Step Cassette.
| Device ID | K992397 |
| 510k Number | K992397 |
| Device Name: | ACCUNATE-ONE STEP, ACCUNATE-ONE STEP CASSETTE |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| 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 | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-19 |
| Decision Date | 1999-08-26 |
| Summary: | summary |