The following data is part of a premarket notification filed by Turklab Medical Devices Inc with the FDA for Rapidan Optima Early Pregnancy Test And Toyo Pregnancy Test.
| Device ID | K081150 |
| 510k Number | K081150 |
| Device Name: | RAPIDAN OPTIMA EARLY PREGNANCY TEST AND TOYO PREGNANCY TEST |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | TURKLAB MEDICAL DEVICES INC 10040 SK. ATATURK ORGANIZE SANAYI BOLGESI CIGLI Izmir,, TR 35100 |
| Contact | Hilda Cil |
| Correspondent | Hilda Cil TURKLAB MEDICAL DEVICES INC 10040 SK. ATATURK ORGANIZE SANAYI BOLGESI CIGLI Izmir,, TR 35100 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-23 |
| Decision Date | 2009-06-16 |
| Summary: | summary |