Forsure One Step Dip & Read (X) Drug Screen Test
FDA 510(k) K061617 · Tianjin New Bay Bioresearch Co., Ltd.
510(k) numberK061617
Submission
- Device name
- Forsure One Step Dip & Read (X) Drug Screen Test
- Applicant
- Tianjin New Bay Bioresearch Co., Ltd.
Carlsbad, CA, US - Received
- June 9, 2006
- Decision date
- November 22, 2006
- 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 |
|---|---|---|
| K130275 | Quikscreen Multi (Mdma and Opi) OTC Drug Cup TestDJG · Traditional | 09/26/2013SE |
| K122064 | Forsure One Step Buprenorphine Cup Test DeviceDJG · Traditional | 05/07/2013SE |
| K112449 | Quikresponse One Step Midstream Early Pregrancy TestLCX · Traditional | 09/24/2012SE |
| K071489 | Homecheck Multiple Drug Cup TestDKZ · Traditional | 03/28/2008SE |
| K073431 | Forsure Ifob Duel Sample Fecal Occult Blood Test Device (for Professional and Home Use)…KHE · Special | 01/14/2008SE |
| K052520 | Rapid Forsure One Step Multiple Drug (Up to 6) Screen Test Device for Amphetamine…DJG · Traditional | 04/24/2006SE |
| K052882 | Forsure Rapid One Step Multiple(X) Abuse Drug Screen Test Cup DeviceDKZ · Traditional | 02/15/2006SE |
| K052208 | Glucose PilotNBW · Traditional | 12/09/2005SE |
| K042988 | Rapid One Step Buprenorphine Test CardDJG · Traditional | 05/12/2005SE |
| K042990 | For Sure One Step Buprenorphine Test StripDJG · Traditional | 05/10/2005SE |
Questions and answers
When was Forsure One Step Dip & Read (X) Drug Screen Test cleared by the FDA?
Forsure One Step Dip & Read (X) Drug Screen Test (K061617) received a 510(k) decision of Substantially Equivalent on November 22, 2006, 166 days after the submission was received.
What is the product code of K061617?
The FDA product code is DKZ – Enzyme Immunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.