Bionexa Single and Multi-Strip Cassette/Dipstick Doa Screen Panels ( Amp, Bar, Bzo, Coc, Met, MTD, Mor, PCP, Tca, THC,
FDA 510(k) K080467 · Applied Dna Technologies, Inc.
510(k) numberK080467
Submission
- Device name
- Bionexa Single and Multi-Strip Cassette/Dipstick Doa Screen Panels ( Amp, Bar, Bzo, Coc, Met, MTD, Mor, PCP, Tca, THC,
- Applicant
- Applied Dna Technologies, Inc.
Mission Viejo, CA, US - Received
- February 21, 2008
- Decision date
- November 25, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LDJ – Enzyme Immunoassay, Cannabinoids
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3870
- Specialty
- Clinical Toxicology
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More from Healgen Scientific,, LLC
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|---|---|---|
| K071030 | Bionexia HCG Pregnancy Serum/Urine Cassette and Dipstick Tests, Models 08-HCGC and 02-HCGCJHI · Traditional | 06/29/2007SE |
| K070921 | Bionexia HCG Pregnancy Cassette and Dipstick Tests, Model 08-HCG and 02-HCGJHI · Traditional | 06/29/2007SE |
| K061005 | Accustep Doa Single and Multi-Strip Screen PanelsDKZ · Traditional | 10/04/2006SE |
Questions and answers
When was Bionexa Single and Multi-Strip Cassette/Dipstick Doa Screen Panels ( Amp, Bar, Bzo, Coc, Met, MTD, Mor, PCP, Tca, THC, cleared by the FDA?
Bionexa Single and Multi-Strip Cassette/Dipstick Doa Screen Panels ( Amp, Bar, Bzo, Coc, Met, MTD, Mor, PCP, Tca, THC, (K080467) received a 510(k) decision of Substantially Equivalent on November 25, 2008, 278 days after the submission was received.
What is the product code of K080467?
The FDA product code is LDJ – Enzyme Immunoassay, Cannabinoids, a Class II (moderate risk) device regulated under 21 CFR 862.3870.