# Germaine Laboratories, Inc.

- Location (FDA's records): San Antonio, TX
- FDA decisions: 8 (1997–2005): 8 510(k) clearances
- Product codes: DHA (4), JHI (2), CEN (1), LCX (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 1 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Ani Biotech OY: 1 (https://510kreport.com/company/ani-biotech)

## Its most-cited devices
- K980531: Aimstep Pregnancy (1998), cited by 1

## Recent decisions
- K051727: Aimstick Urine Reagent Strips (Oct 26, 2005)
- K013857: Aimstep Pregnancy (Jan 22, 2002)
- K991369: Accudip Home Pregnancy and/or Aimstick Pregnancy (May 10, 1999)
- K981165: Aimstep Combo Pregnancy, 1 Test, 30 Test, 50 Test, 100 Test (Apr 16, 1998)
- K980531: Aimstep Pregnancy (Mar 6, 1998)
- K974512: Aimstick PBD Combo Pregnancy (Jan 2, 1998)
- K974368: Aimstick PBD Pregnancy (Jan 2, 1998)
- K973825: Midstream Home Regnancy Test (Dec 19, 1997)

Source page: https://510kreport.com/company/germaine-laboratories