The following data is part of a premarket notification filed by Cenogenics Corp. with the FDA for Accunate One-step,accunate One-step Cassette, Accunate-choice, Accunate Home Pregnancy Test.
| Device ID | K030533 |
| 510k Number | K030533 |
| Device Name: | ACCUNATE ONE-STEP,ACCUNATE ONE-STEP CASSETTE, ACCUNATE-CHOICE, ACCUNATE HOME PREGNANCY TEST |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | CENOGENICS CORP. 100 RT. 520 Morganville, NJ 07751 |
| Contact | Nitz Katz |
| Correspondent | Nitz Katz CENOGENICS CORP. 100 RT. 520 Morganville, NJ 07751 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-14 |
| Decision Date | 2003-04-17 |
| Summary: | summary |