Armkel, LLC: FDA filings under this applicant name
FDA lists 68 510(k) clearances under the applicant name “Armkel, LLC” (first 1979, latest 2004), across 30 product codes in 5 review panels. Median 510(k) review time under this name: 65 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 |
|---|---|---|---|
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 10 | 10 |
| HIS | Condom | 7 | 7 |
| JHJ | Agglutination Method, Human Chorionic Gonadotropin | 6 | 6 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 3 | 3 |
| GTJ | Antisera, All Groups, N. Meningitidis | 3 | 3 |
| GTZ | Antisera, All Groups, Streptococcus Spp. | 3 | 3 |
| GWC | Antisera, All Types, Streptococcus Pneumoniae | 3 | 3 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 3 | 3 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 3 | 3 |
| KTN | System, Test, Infectious Mononucleosis | 3 | 3 |
Plus 20 more product codes.
Review panels
- Clinical Chemistry (29)
- Microbiology (24)
- Obstetrics and Gynecology (9)
- Immunology (5)
- Dental (1)
Most recent Armkel, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K040866 | FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TEST | LCX | 2004-10-19 | 200 |
| K030258 | FIRST RESPONSE PREGNANCY TEST | LCX | 2003-02-25 | 32 |
| K023405 | TROJAN MINT TINGLE BRAND LATEX CONDOMS | HIS | 2002-12-16 | 67 |
| K013433 | TROJAN PASSION BERRY GEL | NUC | 2002-03-05 | 140 |
| K013614 | TROJAN CRYSTAL CLEAR LIQUID | NUC | 2002-02-01 | 88 |
| K001212 | TROJAN EXTRA LARGE LATEX CONDOM | HIS | 2000-05-09 | 25 |
| K000748 | TROJAN LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT | HIS | 2000-04-06 | 29 |
| K992232 | FIRST RESPONSE 1-STEP PREGNANCY | LCX | 1999-12-21 | 172 |
| K973352 | BRAND NAME *1-STEP PREGNANCY | LCX | 1997-10-27 | 52 |
| K973310 | TBD* ONE-STEP OVULATION PREDICTOR TEST | CEP | 1997-10-27 | 54 |
58 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Armkel, LLC.
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 Armkel, LLC?
FDA lists 68 510(k) clearances under the applicant name “Armkel, LLC” (first 1979, latest 2004), across 30 product codes in 5 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Armkel, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Armkel, LLC is 65 days.
Which FDA product codes appear under Armkel, LLC?
The most frequent FDA product codes under this applicant name are LCX (Kit, Test, Pregnancy, Hcg, Over The Counter, 10); HIS (Condom, 7); JHJ (Agglutination Method, Human Chorionic Gonadotropin, 6).
Next steps
- See all 68 Armkel, LLC clearances with predicates and recalls
- Run predicate analysis for product code LCX, Armkel, LLC'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.