Company ยท US
Germaine Laboratories, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1997 to 2005. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 26, 2005 | K051727 | AIMSTICK URINE REAGENT STRIPS Germaine Laboratories, Inc. | CEN |
| Jan 22, 2002 | K013857 | AIMSTEP PREGNANCY Germaine Laboratories, Inc. | DHA |
| May 10, 1999 | K991369 | ACCUDIP HOME PREGNANCY AND/OR AIMSTICK PREGNANCY Germaine Laboratories, Inc. | LCX |
| Apr 16, 1998 | K981165 | AIMSTEP COMBO PREGNANCY, 1 TEST, 30 TEST, 50 TEST, 100 TEST Germaine Laboratories, Inc. | JHI |
| Mar 6, 1998 | K980531 | AIMSTEP PREGNANCY Germaine Laboratories, Inc. | JHI |
| Jan 2, 1998 | K974512 | AIMSTICK PBD COMBO PREGNANCY Germaine Laboratories, Inc. | DHA |
| Jan 2, 1998 | K974368 | AIMSTICK PBD PREGNANCY Germaine Laboratories, Inc. | DHA |
| Dec 19, 1997 | K973825 | MIDSTREAM HOME REGNANCY TEST Germaine Laboratories, Inc. | DHA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||