Germaine Laboratories, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Germaine Laboratories, Inc.” (first 1997, latest 2005), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 38 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DHA | System, Test, Human Chorionic Gonadotropin | 4 | 4 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 2 | 2 |
| CEN | Dye-Indicator, Ph (Urinary, Non-Quantitative) | 1 | 1 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 1 | 1 |
Review panels
Most recent Germaine Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K051727 | AIMSTICK URINE REAGENT STRIPS | CEN | 2005-10-26 | 120 |
| K013857 | AIMSTEP PREGNANCY | DHA | 2002-01-22 | 62 |
| K991369 | ACCUDIP HOME PREGNANCY AND/OR AIMSTICK PREGNANCY | LCX | 1999-05-10 | 20 |
| K981165 | AIMSTEP COMBO PREGNANCY, 1 TEST, 30 TEST, 50 TEST, 100 TEST | JHI | 1998-04-16 | 16 |
| K980531 | AIMSTEP PREGNANCY | JHI | 1998-03-06 | 23 |
| K974512 | AIMSTICK PBD COMBO PREGNANCY | DHA | 1998-01-02 | 32 |
| K974368 | AIMSTICK PBD PREGNANCY | DHA | 1998-01-02 | 43 |
| K973825 | MIDSTREAM HOME REGNANCY TEST | DHA | 1997-12-19 | 73 |
Recalls
openFDA lists no recalls under a recalling firm named Germaine Laboratories, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Germaine Laboratories, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Germaine Laboratories, Inc.” (first 1997, latest 2005), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Germaine Laboratories, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Germaine Laboratories, Inc. is 38 days.
Which FDA product codes appear under Germaine Laboratories, Inc.?
The most frequent FDA product codes under this applicant name are DHA (System, Test, Human Chorionic Gonadotropin, 4); JHI (Visual, Pregnancy Hcg, Prescription Use, 2); CEN (Dye-Indicator, Ph (Urinary, Non-Quantitative), 1).
Next steps
- See all 8 Germaine Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DHA, Germaine Laboratories, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.