The following data is part of a premarket notification filed by Germaine Laboratories, Inc. with the FDA for Aimstick Urine Reagent Strips.
| Device ID | K051727 |
| 510k Number | K051727 |
| Device Name: | AIMSTICK URINE REAGENT STRIPS |
| Classification | Dye-indicator, Ph (urinary, Non-quantitative) |
| Applicant | GERMAINE LABORATORIES, INC. 4139 GARDENDALE CENTER, SUITE 101 San Antonio, TX 78229 |
| Contact | Martin O'connor |
| Correspondent | Martin O'connor GERMAINE LABORATORIES, INC. 4139 GARDENDALE CENTER, SUITE 101 San Antonio, TX 78229 |
| Product Code | CEN |
| CFR Regulation Number | 862.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-28 |
| Decision Date | 2005-10-26 |
| Summary: | summary |