Company ยท US
Armkel, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 1979 to 2004. Name variants (Inc, Corp, punctuation) are merged.
68510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 10 |
| HIS | Condom | 7 |
| JHJ | Agglutination Method, Human Chorionic Gonadotropin | 6 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 3 |
| GTJ | Antisera, All Groups, N. Meningitidis | 3 |
| GTZ | Antisera, All Groups, Streptococcus Spp. | 3 |
| GWC | Antisera, All Types, Streptococcus Pneumoniae | 3 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 3 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 3 |
| KTN | System, Test, Infectious Mononucleosis | 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 |
| CGI | Radioimmunoassay, Estriol | 1 |
| DCN | System, Test, C-Reactive Protein | 1 |
| DHC | System, Test, Systemic Lupus Erythematosus | 1 |
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 1 |
| GRM | Antisera, All Groups, Salmonella Spp. | 1 |
| GRO | Antisera, Fluorescent, All Types, Hemophilus Spp. | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 19, 2004 | K040866 | FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TEST Armkel, LLC | LCX |
| Feb 25, 2003 | K030258 | FIRST RESPONSE PREGNANCY TEST Armkel, LLC | LCX |
| Dec 16, 2002 | K023405 | TROJAN MINT TINGLE BRAND LATEX CONDOMS Armkel, LLC | HIS |
| Mar 5, 2002 | K013433 | TROJAN PASSION BERRY GEL Armkel, LLC | NUC |
| Feb 1, 2002 | K013614 | TROJAN CRYSTAL CLEAR LIQUID Armkel, LLC | NUC |
| May 9, 2000 | K001212 | TROJAN EXTRA LARGE LATEX CONDOM Armkel, LLC | HIS |
| Apr 6, 2000 | K000748 | TROJAN LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT Armkel, LLC | HIS |
| Dec 21, 1999 | K992232 | FIRST RESPONSE 1-STEP PREGNANCY Armkel, LLC | LCX |
| Oct 27, 1997 | K973352 | BRAND NAME *1-STEP PREGNANCY Armkel, LLC | LCX |
| Oct 27, 1997 | K973310 | TBD* ONE-STEP OVULATION PREDICTOR TEST Armkel, LLC | CEP |
| Mar 3, 1997 | K963318 | LEGIONELLA IGG/IGM ELISA TEST SYSTEM Armkel, LLC | LHL |
| Feb 24, 1997 | K962558 | CHLAMYDIA IGG ELISA TEST SYSTEM Armkel, LLC | LJC |
| Feb 4, 1997 | K963645 | HERPES GROUP IGG ELISA TEST SYSTEM Armkel, LLC | LGC |
| Jul 30, 1996 | K961221 | PYLORI IGG ELISA TEST SYSTEM Armkel, LLC | LYR |
| Jul 10, 1996 | K962183 | BRAND NAME 1-STEP PREGNANCY TEST-MAY BE MARKETED UNDER FIRST RESPONSE, ANSWER, OR OTHER BRAND NAMES Armkel, LLC | LCX |
| May 31, 1996 | K961712 | TBD AT-HOME PREGNANCY TEST Armkel, LLC | LCX |
| Oct 3, 1995 | K953581 | FIRST RESPONSE OVULATION PREDICTOR TEST Armkel, LLC | CEP |
| Oct 17, 1991 | K914304 | FIRST RESPONSE(R) ONE-STEP Armkel, LLC | LCX |
| Mar 29, 1991 | K902305 | TROJAN NATURALAMB NATURAL MEMBRANE CONDOM W/SPERM. Armkel, LLC | HIS |
| Feb 19, 1991 | K904000 | TROJAN(R) EXTRA STR LATEX CONDOM W/SPERM SILI LUBR Armkel, LLC | HIS |
| Feb 26, 1990 | K900625 | MONO-PLUS POSITIVE AND NEGATIVE CONTROL SET Armkel, LLC | KTN |
| Feb 26, 1990 | K896875 | POSITIVE AND NEGATIVE HCG SERUM CONTROLS Armkel, LLC | JJX |
| Jan 23, 1990 | K895640 | MAGNUM PLUS LATEX CONDOM W/SPERMICIDAL LUBRICANT Armkel, LLC | HIS |
| Aug 31, 1989 | K894181 | POSITIVE AND NEGATIVE HCG URINE CONTROLS Armkel, LLC | JJX |
| Apr 4, 1989 | K890863 | TROJAN FOR WOMEN Armkel, LLC | HIS |
| Feb 7, 1989 | K885004 | BACTIGEN(R) N. MENINGITIDIS Armkel, LLC | GTJ |
| Feb 7, 1989 | K885003 | BACTIGEN(R) GROUP B STREPTOCOCCUS TEST Armkel, LLC | GTZ |
| Feb 7, 1989 | K884967 | BACTIGEN(R) H. INFLUENZAE TYPE B Armkel, LLC | GRP |
| Feb 7, 1989 | K884966 | BACTIGEN(R) S. PNEUMONIAE Armkel, LLC | GWC |
| Feb 7, 1989 | K884965 | BACTIGEN(R) MENINGITIDIS PANEL Armkel, LLC | GWC |
| Dec 20, 1988 | K883709 | MODIFICATION OF MONO-PLUS(TM) Armkel, LLC | KTN |
| Oct 15, 1987 | K871426 | VIROGEN HSV ANTIBODY TEST Armkel, LLC | GQO |
| Oct 2, 1987 | K871241 | ANSWER OVULATION TEST KIT Armkel, LLC | CEP |
| Aug 27, 1987 | K872114 | BACTIGEN GROUP B STREPTOCOCCUS-CS TEST Armkel, LLC | GTZ |
| Apr 22, 1987 | K870813 | BACTIGEN SALMONELLA-SHIGELLA TEST Armkel, LLC | GRM |
| Sep 29, 1986 | K863198 | PREGNASLIDE Armkel, LLC | JHJ |
| Jul 3, 1986 | K862008 | MONO-LATEX (TM) SLIDE TEST Armkel, LLC | KTN |
| Apr 11, 1986 | K860090 | ANSWER PLUS AT HOME PREGNANCY TEST Armkel, LLC | LCX |
| Mar 4, 1986 | K854430 | RIGIDENT CREAM Armkel, LLC | KOT |
| Nov 12, 1985 | K853399 | VIROGEN ROTATEST SLIDE TEST Armkel, LLC | LIQ |
| Oct 17, 1985 | K852928 | VIROGEN HERPES SLIDE TEST Armkel, LLC | GQO |
| Jun 28, 1985 | K852274 | ANSWER Armkel, LLC | LCX |
| May 29, 1985 | K850772 | BACTIGEN GROUP B STREPTOCOCCUS TEST Armkel, LLC | GTZ |
| May 21, 1985 | K844436 | VIROGEN RUBELLA MICROTITER TEST Armkel, LLC | LQN |
| May 20, 1985 | K844435 | VIROGEN RUBELLA SLIDE TEST Armkel, LLC | LQN |
| May 1, 1985 | K850992 | PREGNA-ZYME Armkel, LLC | JHI |
| Sep 14, 1984 | K843238 | ANSWER ONE-DAY Armkel, LLC | LCX |
| Jul 6, 1984 | K841907 | BACTIGEN - N.MENNINIGITIDIS TEST Armkel, LLC | GTJ |
| Sep 26, 1983 | K831887 | BACTIGEN S. PNEUMONIAE Armkel, LLC | GWC |
| Aug 11, 1983 | K831775 | UCG-BETA SLIDE MONOCLONAL Armkel, LLC | JHJ |
Newest 50 of 68.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||