The following data is part of a premarket notification filed by Germaine Laboratories, Inc. with the FDA for Accudip Home Pregnancy And/or Aimstick Pregnancy.
| Device ID | K991369 |
| 510k Number | K991369 |
| Device Name: | ACCUDIP HOME PREGNANCY AND/OR AIMSTICK PREGNANCY |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| 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 | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-20 |
| Decision Date | 1999-05-10 |
| Summary: | summary |