Polymed Therapeutics Fastep Dipstick Drugs of Abuse Screen Device and Dipcard Drugs of Abuse Screen Device
FDA 510(k) K121065 · Polymed Therapeutics, Inc.
510(k) numberK121065
Submission
- Device name
- Polymed Therapeutics Fastep Dipstick Drugs of Abuse Screen Device and Dipcard Drugs of Abuse Screen Device
- Applicant
- Polymed Therapeutics, Inc.
Gaithersburg, MD, US - Received
- April 6, 2012
- Decision date
- May 24, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DKZ – Enzyme Immunoassay, Amphetamine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3100
- Specialty
- Clinical Toxicology
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More from Alfa Scientific Designs, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K142408 | FaStep Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), FaStep…LDJ · Traditional | 09/25/2014SE |
| K132834 | Fastep S10 HCG Serum/Urine Combo TestJHI · Traditional | 01/09/2014SE |
| K122907 | Fastep At-Home Pregnancy, HCG, Over the CounterLCX · Traditional | 03/14/2013SE |
| K112101 | Fastep HCG Pregancy Serum/Urine Cassette and Dipstick TestsJHI · Traditional | 07/17/2012SE |
Questions and answers
When was Polymed Therapeutics Fastep Dipstick Drugs of Abuse Screen Device and Dipcard Drugs of Abuse Screen Device cleared by the FDA?
Polymed Therapeutics Fastep Dipstick Drugs of Abuse Screen Device and Dipcard Drugs of Abuse Screen Device (K121065) received a 510(k) decision of Substantially Equivalent on May 24, 2013, 413 days after the submission was received.
What is the product code of K121065?
The FDA product code is DKZ – Enzyme Immunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.