Rapidone-Buprenorphine Test
FDA 510(k) K060760 · American Bio Medica Corp.
510(k) numberK060760
Submission
- Device name
- Rapidone-Buprenorphine Test
- Applicant
- American Bio Medica Corp.
Columbia, MD, US - Received
- March 21, 2006
- Decision date
- August 7, 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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| K053359 | RapidtoxDKZ · Special | 05/25/2006SE |
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| K030835 | 'Rapid One' - Propoxyphene TestJXN · Traditional | 05/22/2003SE |
| K023869 | 'RAPIDTEC'-5M-MULTIPLE Dip TestDJR · Traditional | 04/30/2003SE |
| K021114 | 'Rapidtec' 5A Multiple Dip TestDKZ · Traditional | 07/23/2002SE |
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Questions and answers
When was Rapidone-Buprenorphine Test cleared by the FDA?
Rapidone-Buprenorphine Test (K060760) received a 510(k) decision of Substantially Equivalent on August 7, 2006, 139 days after the submission was received.
What is the product code of K060760?
The FDA product code is DJG – Enzyme Immunoassay, Opiates, a Class II (moderate risk) device regulated under 21 CFR 862.3650.