Armkel, LLC
Medical device manufacturer in Princeton, NJ.
68510(k) clearances
0PMA approvals
0recalls
Device types
- LCX Kit, Test, Pregnancy, Hcg, Over The Counter 10
- HIS Condom 7
- JHJ Agglutination Method, Human Chorionic… 6
- KTN System, Test, Infectious Mononucleosis 3
- CEP Radioimmunoassay, Luteinizing Hormone 3
- JHI Visual, Pregnancy Hcg, Prescription Use 3
- GTZ Antisera, All Groups, Streptococcus Spp. 3
- GWC Antisera, All Types, Streptococcus Pneumoniae 3
- JJX Single (Specified) Analyte Controls… 3
- GTJ Antisera, All Groups, N. Meningitidis 3
- DHR System, Test, Rheumatoid Factor 2
- GQO Antisera, Cf, Herpesvirus Hominis 1,2 2
- LQN Latex Agglutination Assay, Rubella 2
- NUC Lubricant, Personal 2
- DHC System, Test, Systemic Lupus Erythematosus 1
- DCN System, Test, C-Reactive Protein 1
- JMF Radioimmunoassay, Human Placental Lactogen 1
- JLS Radioimmunoassay, Progesterone 1
- DHN Antinuclear Antibody, Indirect… 1
- GRO Antisera, Fluorescent, All Types… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K040866 | First Response One-Step Digital Pregnancy TestLCX · Traditional | 10/19/2004SE |
| K030258 | First Response Pregnancy TestLCX · Traditional | 02/25/2003SE |
| K023405 | Trojan Mint Tingle Brand Latex CondomsHIS · Abbreviated | 12/16/2002SE |
| K013433 | Trojan Passion Berry GelNUC · Traditional | 03/05/2002SE |
| K013614 | Trojan Crystal Clear LiquidNUC · Traditional | 02/01/2002SE |
| K001212 | Trojan Extra Large Latex CondomHIS · Special | 05/09/2000SE |
| K000748 | Trojan Latex Condom with Male Genital Desensitizer LubricantHIS · Special | 04/06/2000SE |
| K992232 | First Response 1-STEP PregnancyLCX · Traditional | 12/21/1999SE |
| K973352 | Brand Name *1-STEP PregnancyLCX · Traditional | 10/27/1997SE |
| K973310 | Tbd* One-Step Ovulation Predictor TestCEP · Traditional | 10/27/1997SE |
| K963318 | Legionella Igg/Igm Elisa Test SystemLHL · Traditional | 03/03/1997SE |
| K962558 | Chlamydia Igg Elisa Test SystemLJC · Traditional | 02/24/1997SE |
| K963645 | Herpes Group Igg Elisa Test SystemLGC · Traditional | 02/04/1997SE |
| K961221 | Pylori Igg Elisa Test SystemLYR · Traditional | 07/30/1996SE |
| K962183 | Brand Name 1-STEP Pregnancy Test-May Be Marketed Under First Response, Answer, or Other…LCX · Traditional | 07/10/1996SE |
| K961712 | TBD At-Home Pregnancy TestLCX · Traditional | 05/31/1996SE |
| K953581 | First Response Ovulation Predictor TestCEP · Traditional | 10/03/1995SE |
| K914304 | First Response(R) One-StepLCX · Traditional | 10/17/1991SE |
| K902305 | Trojan Naturalamb Natural Membrane Condom W/Sperm.HIS · Traditional | 03/29/1991SE |
| K904000 | Trojan(R) Extra STR Latex Condom W/Sperm Sili LubrHIS · Traditional | 02/19/1991SE |
| K900625 | Mono-Plus Positive and Negative Control SetKTN · Traditional | 02/26/1990SE |
| K896875 | Positive and Negative HCG Serum ControlsJJX · Traditional | 02/26/1990SE |
| K895640 | Magnum Plus Latex Condom W/Spermicidal LubricantHIS · Traditional | 01/23/1990SE |
| K894181 | Positive and Negative HCG Urine ControlsJJX · Traditional | 08/31/1989SE |
| K890863 | Trojan for WomenHIS · Traditional | 04/04/1989SE |
| K885004 | Bactigen(R) N. MeningitidisGTJ · Traditional | 02/07/1989SE |
| K885003 | Bactigen(R) Group B Streptococcus TestGTZ · Traditional | 02/07/1989SE |
| K884967 | Bactigen(R) H. Influenzae Type BGRP · Traditional | 02/07/1989SE |
| K884966 | Bactigen(R) S. PneumoniaeGWC · Traditional | 02/07/1989SE |
| K884965 | Bactigen(R) Meningitidis PanelGWC · Traditional | 02/07/1989SE |
| K883709 | Modification of Mono-Plus(Tm)KTN · Traditional | 12/20/1988SE |
| K871426 | Virogen HSV Antibody TestGQO · Traditional | 10/15/1987SE |
| K871241 | Answer Ovulation Test KitCEP · Traditional | 10/02/1987SE |
| K872114 | Bactigen Group B Streptococcus-Cs TestGTZ · Traditional | 08/27/1987SE |
| K870813 | Bactigen Salmonella-Shigella TestGRM · Traditional | 04/22/1987SE |
| K863198 | PregnaslideJHJ · Traditional | 09/29/1986SE |
| K862008 | Mono-Latex (TM) Slide TestKTN · Traditional | 07/03/1986SE |
| K860090 | Answer Plus at Home Pregnancy TestLCX · Traditional | 04/11/1986SE |
| K854430 | Rigident CreamKOT · Traditional | 03/04/1986SE |
| K853399 | Virogen Rotatest Slide TestLIQ · Traditional | 11/12/1985SE |
| K852928 | Virogen Herpes Slide TestGQO · Traditional | 10/17/1985SE |
| K852274 | AnswerLCX · Traditional | 06/28/1985SE |
| K850772 | Bactigen Group B Streptococcus TestGTZ · Traditional | 05/29/1985SE |
| K844436 | Virogen Rubella Microtiter TestLQN · Traditional | 05/21/1985SE |
| K844435 | Virogen Rubella Slide TestLQN · Traditional | 05/20/1985SE |
| K850992 | Pregna-ZymeJHI · Traditional | 05/01/1985SE |
| K843238 | Answer One-DayLCX · Traditional | 09/14/1984SE |
| K841907 | Bactigen - N.Menninigitidis TestGTJ · Traditional | 07/06/1984SE |
| K831887 | Bactigen S. PneumoniaeGWC · Traditional | 09/26/1983SE |
| K831775 | Ucg-Beta Slide MonoclonalJHJ · Traditional | 08/11/1983SE |
| K823880 | Bactigen-N. MeningitidisGTJ · Traditional | 03/09/1983SE |
| K823753 | Genesis B-HcgJHI · Traditional | 01/24/1983SE |
| K821941 | Rheumatoid Factor Reference Prepara.DHR · Traditional | 08/27/1982SE |
| K821742 | Positive & Negative HCG Urine ControlsJJX · Traditional | 07/02/1982SE |
| K812924 | Answer (R)JHJ · Traditional | 11/02/1981SE |
| K812882 | RheumatexDHR · Traditional | 10/26/1981SE |
| K812881 | Immunex CRPDCN · Traditional | 10/26/1981SE |
| K811371 | Natal-Tec EstriolCGI · Traditional | 05/29/1981SE |
| K811370 | Natal-Tec HPLJMF · Traditional | 05/29/1981SE |
| K811369 | Natal-Tec ProgesteroneJLS · Traditional | 05/29/1981SE |
| K802999 | Beta-Tec QualitativeJHI · Traditional | 12/22/1980SE |
| K802660 | Answer At-Home Pregnancy Test KitJHJ · Traditional | 11/24/1980SE |
| K802435 | Ucg-Beta SlideJHJ · Traditional | 10/23/1980SE |
| K802421 | Ucg-Beta StatJHJ · Traditional | 10/23/1980SE |
| K801046 | AnatonDHN · Traditional | 05/14/1980SE |
| K800493 | Bactogen-H. Influenzae Type BGRO · Traditional | 04/04/1980SE |
| K790549 | Heating Block, Wampole 37 CJRG · Traditional | 05/03/1979SE |
| K782129 | Lupo-TecDHC · Traditional | 03/12/1979SE |