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 |