POLYMED THERAPEUTICS FASTEP DIPSTICK DRUGS OF ABUSE SCREEN DEVICE AND DIPCARD DRUGS OF ABUSE SCREEN DEVICE— 510(k) K121065
Substantially EquivalentPolymed Therapeutics, Inc.
FDA 510(k) clearance K121065 for POLYMED THERAPEUTICS FASTEP DIPSTICK DRUGS OF ABUSE SCREEN DEVICE AND DIPCARD DRUGS OF ABUSE SCREEN DEVICE, Substantially Equivalent on 2013-05-24. Applicant: Polymed Therapeutics, Inc.. Device class: 2.
Clearance details
- Applicant
- Polymed Therapeutics, Inc.
- Product code
- Code DKZ
- Device class
- Class 2
- Regulation
- 21 CFR 862.3100
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gaithersburg, MD, US
Recent devices under product code DKZ
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- K132834 — FASTEP S10 HCG SERUM/URINE COMBO TEST
- K122907 — FASTEP AT-HOME PREGNANCY, HCG, OVER THE COUNTER
- K112101 — FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS
Data sourced from openFDA. This site is unofficial and independent of the FDA.