The following data is part of a premarket notification filed by Germaine Laboratories, Inc. with the FDA for Midstream Home Regnancy Test.
| Device ID | K973825 |
| 510k Number | K973825 |
| Device Name: | MIDSTREAM HOME REGNANCY TEST |
| Classification | System, Test, Human Chorionic Gonadotropin |
| Applicant | GERMAINE LABORATORIES, INC. 4203 GARDENDALE CENTER, #230 San Antonio, TX 78229 |
| Contact | Martin O'connor |
| Correspondent | Martin O'connor GERMAINE LABORATORIES, INC. 4203 GARDENDALE CENTER, #230 San Antonio, TX 78229 |
| Product Code | DHA |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-07 |
| Decision Date | 1997-12-19 |
| Summary: | summary |