The following data is part of a premarket notification filed by Disease Detection International, Inc. with the FDA for Pregna-card(tm) A Visual Home Pregnancy Test.
| Device ID | K883430 |
| 510k Number | K883430 |
| Device Name: | PREGNA-CARD(TM) A VISUAL HOME PREGNANCY TEST |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | DISEASE DETECTION INTERNATIONAL, INC. 17935 SKY PARK CIRCLE, SUITE D Irvine, CA 92714 |
| Contact | Siegfried Krutzik |
| Correspondent | Siegfried Krutzik DISEASE DETECTION INTERNATIONAL, INC. 17935 SKY PARK CIRCLE, SUITE D Irvine, CA 92714 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-15 |
| Decision Date | 1989-01-30 |