Armkel, LLC
Cranbury, NJ, US
Armkel, LLC appears in FDA device records in Cranbury, NJ. FDA records list 68 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 68
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 68FDA records hold 68 510(k) clearances for Armkel, LLC between 1979 and 2004. The busiest year on record is 1985, with 7. The most recent is 2004, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1979 | 2 |
| 1980 | 6 |
| 1981 | 6 |
| 1982 | 2 |
| 1983 | 4 |
| 1984 | 2 |
| 1985 | 7 |
| 1986 | 4 |
| 1987 | 4 |
| 1988 | 1 |
| 1989 | 7 |
| 1990 | 3 |
| 1991 | 3 |
| 1995 | 1 |
| 1996 | 3 |
| 1997 | 5 |
| 1999 | 1 |
| 2000 | 2 |
| 2002 | 3 |
| 2003 | 1 |
| 2004 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K040866 | FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TEST | LCX | Substantially Equivalent | |
| K030258 | FIRST RESPONSE PREGNANCY TEST | LCX | Substantially Equivalent | |
| K023405 | TROJAN MINT TINGLE BRAND LATEX CONDOMS | HIS | Substantially Equivalent | |
| K013433 | TROJAN PASSION BERRY GEL | NUC | Substantially Equivalent | |
| K013614 | TROJAN CRYSTAL CLEAR LIQUID | NUC | Substantially Equivalent | |
| K001212 | TROJAN EXTRA LARGE LATEX CONDOM | HIS | Substantially Equivalent | |
| K000748 | TROJAN LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT | HIS | Substantially Equivalent | |
| K992232 | FIRST RESPONSE 1-STEP PREGNANCY | LCX | Substantially Equivalent | |
| K973352 | BRAND NAME *1-STEP PREGNANCY | LCX | Substantially Equivalent | |
| K973310 | TBD* ONE-STEP OVULATION PREDICTOR TEST | CEP | Substantially Equivalent | |
| K963318 | LEGIONELLA IGG/IGM ELISA TEST SYSTEM | LHL | Substantially Equivalent | |
| K962558 | CHLAMYDIA IGG ELISA TEST SYSTEM | LJC | Substantially Equivalent | |
| K963645 | HERPES GROUP IGG ELISA TEST SYSTEM | LGC | Substantially Equivalent | |
| K961221 | PYLORI IGG ELISA TEST SYSTEM | LYR | Substantially Equivalent | |
| K962183 | BRAND NAME 1-STEP PREGNANCY TEST-MAY BE MARKETED UNDER FIRST RESPONSE, ANSWER, OR OTHER BRAND NAMES | LCX | Substantially Equivalent | |
| K961712 | TBD AT-HOME PREGNANCY TEST | LCX | Substantially Equivalent | |
| K953581 | FIRST RESPONSE OVULATION PREDICTOR TEST | CEP | Substantially Equivalent | |
| K914304 | FIRST RESPONSE(R) ONE-STEP | LCX | Substantially Equivalent | |
| K902305 | TROJAN NATURALAMB NATURAL MEMBRANE CONDOM W/SPERM. | HIS | Substantially Equivalent | |
| K904000 | TROJAN(R) EXTRA STR LATEX CONDOM W/SPERM SILI LUBR | HIS | Substantially Equivalent | |
| K900625 | MONO-PLUS POSITIVE AND NEGATIVE CONTROL SET | KTN | Substantially Equivalent | |
| K896875 | POSITIVE AND NEGATIVE HCG SERUM CONTROLS | JJX | Substantially Equivalent | |
| K895640 | MAGNUM PLUS LATEX CONDOM W/SPERMICIDAL LUBRICANT | HIS | Substantially Equivalent | |
| K894181 | POSITIVE AND NEGATIVE HCG URINE CONTROLS | JJX | Substantially Equivalent | |
| K890863 | TROJAN FOR WOMEN | HIS | Substantially Equivalent | |
| K885004 | BACTIGEN(R) N. MENINGITIDIS | GTJ | Substantially Equivalent | |
| K885003 | BACTIGEN(R) GROUP B STREPTOCOCCUS TEST | GTZ | Substantially Equivalent | |
| K884967 | BACTIGEN(R) H. INFLUENZAE TYPE B | GRP | Substantially Equivalent | |
| K884966 | BACTIGEN(R) S. PNEUMONIAE | GWC | Substantially Equivalent | |
| K884965 | BACTIGEN(R) MENINGITIDIS PANEL | GWC | Substantially Equivalent | |
| K883709 | MODIFICATION OF MONO-PLUS(TM) | KTN | Substantially Equivalent | |
| K871426 | VIROGEN HSV ANTIBODY TEST | GQO | Substantially Equivalent | |
| K871241 | ANSWER OVULATION TEST KIT | CEP | Substantially Equivalent | |
| K872114 | BACTIGEN GROUP B STREPTOCOCCUS-CS TEST | GTZ | Substantially Equivalent | |
| K870813 | BACTIGEN SALMONELLA-SHIGELLA TEST | GRM | Substantially Equivalent | |
| K863198 | PREGNASLIDE | JHJ | Substantially Equivalent | |
| K862008 | MONO-LATEX (TM) SLIDE TEST | KTN | Substantially Equivalent | |
| K860090 | ANSWER PLUS AT HOME PREGNANCY TEST | LCX | Substantially Equivalent | |
| K854430 | RIGIDENT CREAM | KOT | Substantially Equivalent | |
| K853399 | VIROGEN ROTATEST SLIDE TEST | LIQ | Substantially Equivalent | |
| K852928 | VIROGEN HERPES SLIDE TEST | GQO | Substantially Equivalent | |
| K852274 | ANSWER | LCX | Substantially Equivalent | |
| K850772 | BACTIGEN GROUP B STREPTOCOCCUS TEST | GTZ | Substantially Equivalent | |
| K844436 | VIROGEN RUBELLA MICROTITER TEST | LQN | Substantially Equivalent | |
| K844435 | VIROGEN RUBELLA SLIDE TEST | LQN | Substantially Equivalent | |
| K850992 | PREGNA-ZYME | JHI | Substantially Equivalent | |
| K843238 | ANSWER ONE-DAY | LCX | Substantially Equivalent | |
| K841907 | BACTIGEN - N.MENNINIGITIDIS TEST | GTJ | Substantially Equivalent | |
| K831887 | BACTIGEN S. PNEUMONIAE | GWC | Substantially Equivalent | |
| K831775 | UCG-BETA SLIDE MONOCLONAL | JHJ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- JHJAgglutination Method, Human Chorionic Gonadotropin
- DHNAntinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
- GTJAntisera, All Groups, N. Meningitidis
- GRMAntisera, All Groups, Salmonella Spp.
- GTZAntisera, All Groups, Streptococcus Spp.
- GRPAntisera, All Types, H. Influenza
- GWCAntisera, All Types, Streptococcus Pneumoniae
- GQOAntisera, Cf, Herpesvirus Hominis 1,2
- GROAntisera, Fluorescent, All Types, Hemophilus Spp.
- JRGBlock, Heating
- KOTCarboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium
- HISCondom
- LJCEnzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)
- LGCEnzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
- LIQEnzyme Linked Immunoabsorbent Assay, Rotavirus
- LYRHelicobacter Pylori
- LCXKit, Test, Pregnancy, Hcg, Over The Counter
- LQNLatex Agglutination Assay, Rubella
- NUCLubricant, Personal
- CGIRadioimmunoassay, Estriol
- JMFRadioimmunoassay, Human Placental Lactogen
- CEPRadioimmunoassay, Luteinizing Hormone
- JLSRadioimmunoassay, Progesterone
- LHLReagents, Antibody, Legionella, Direct & Indirect Fluorescent
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- DCNSystem, Test, C-Reactive Protein
- KTNSystem, Test, Infectious Mononucleosis
- DHRSystem, Test, Rheumatoid Factor
- DHCSystem, Test, Systemic Lupus Erythematosus
- JHIVisual, Pregnancy Hcg, Prescription Use
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain