The following data is part of a premarket notification filed by Germaine Laboratories, Inc. with the FDA for Aimstep Combo Pregnancy, 1 Test, 30 Test, 50 Test, 100 Test.
| Device ID | K981165 |
| 510k Number | K981165 |
| Device Name: | AIMSTEP COMBO PREGNANCY, 1 TEST, 30 TEST, 50 TEST, 100 TEST |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| 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 | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-31 |
| Decision Date | 1998-04-16 |
| Summary: | summary |