Rapid Forsure One Step Multiple Drug (Up to 6) Screen Test Device for Amphetamine, Methamphetamine, Benzoylecgonine, THC
FDA 510(k) K052520 · Tianjin New Bay Bioresearch Co., Ltd.
510(k) numberK052520
Submission
- Device name
- Rapid Forsure One Step Multiple Drug (Up to 6) Screen Test Device for Amphetamine, Methamphetamine, Benzoylecgonine, THC
- Applicant
- Tianjin New Bay Bioresearch Co., Ltd.
Carlsbad, CA, US - Received
- September 14, 2005
- Decision date
- April 24, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DJG – Enzyme Immunoassay, Opiates
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3650
- Specialty
- Clinical Toxicology
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| 510(k) | Device | Decision |
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| 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 |
| K061617 | Forsure One Step Dip & Read (X) Drug Screen TestDKZ · Traditional | 11/22/2006SE |
| 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 Rapid Forsure One Step Multiple Drug (Up to 6) Screen Test Device for Amphetamine, Methamphetamine, Benzoylecgonine, THC cleared by the FDA?
Rapid Forsure One Step Multiple Drug (Up to 6) Screen Test Device for Amphetamine, Methamphetamine, Benzoylecgonine, THC (K052520) received a 510(k) decision of Substantially Equivalent on April 24, 2006, 222 days after the submission was received.
What is the product code of K052520?
The FDA product code is DJG – Enzyme Immunoassay, Opiates, a Class II (moderate risk) device regulated under 21 CFR 862.3650.