FDA 510(k) Applications Submitted by ARMKEL, LLC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K961712 |
05/02/1996 |
TBD AT-HOME PREGNANCY TEST |
ARMKEL, LLC. |
| K962183 |
06/06/1996 |
BRAND NAME 1-STEP PREGNANCY TEST-MAY BE MARKETED UNDER FIRST RESPONSE, ANSWER, OR OTHER BRAND NAMES |
ARMKEL, LLC. |
| K992232 |
07/02/1999 |
FIRST RESPONSE 1-STEP PREGNANCY |
ARMKEL, LLC. |
| K030258 |
01/24/2003 |
FIRST RESPONSE PREGNANCY TEST |
ARMKEL, LLC. |
| K000748 |
03/08/2000 |
TROJAN LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT |
ARMKEL, LLC. |
| K001212 |
04/14/2000 |
TROJAN EXTRA LARGE LATEX CONDOM |
ARMKEL, LLC. |
| K023405 |
10/10/2002 |
TROJAN MINT TINGLE BRAND LATEX CONDOMS |
ARMKEL, LLC. |
| K973310 |
09/03/1997 |
TBD* ONE-STEP OVULATION PREDICTOR TEST |
ARMKEL, LLC. |
| K973352 |
09/05/1997 |
BRAND NAME *1-STEP PREGNANCY |
ARMKEL, LLC. |
| K961221 |
03/20/1996 |
PYLORI IGG ELISA TEST SYSTEM |
ARMKEL, LLC. |
| K962558 |
07/01/1996 |
CHLAMYDIA IGG ELISA TEST SYSTEM |
ARMKEL, LLC. |
| K963318 |
08/23/1996 |
LEGIONELLA IGG/IGM ELISA TEST SYSTEM |
ARMKEL, LLC. |
| K963645 |
09/12/1996 |
HERPES GROUP IGG ELISA TEST SYSTEM |
ARMKEL, LLC. |
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