FDA 510(k) Applications Submitted by Healgen Scientific, LLC
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K123703 |
12/03/2012 |
HEALGEN HCG ONE STEP PREGNANCY TEST (STRIP), HEALGEN HCG ONE STEP PREGNANCY TEST (CASSETTE) |
HEALGEN SCIENTIFIC, LLC |
| K212623 |
08/18/2021 |
Healgen Strep A Rapid Test Strip (Throat Swab) |
Healgen Scientific, LLC |
| K140546 |
03/04/2014 |
HEALGEN THC ONE STEP MARIJUANA TEST , HEALGEN MAMP ONE STEP METHAMPHETAMINE TEST |
HEALGEN SCIENTIFIC, LLC |
| K141647 |
06/19/2014 |
HEALGEN COC ONE STEP COCAINE TEST STRIP:MORHPINE TEST STRIP (CASSETTE, CUP, DIP CARD) |
HEALGEN SCIENTIFIC, LLC |
| K111999 |
07/13/2011 |
HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINAL |
HEALGEN SCIENTIFIC, LLC |
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