Triage Panel for Drugs of Abuse/Tricyclic Antidepressants
FDA 510(k) K955935 · Biosite Incorporated
510(k) numberK955935
Submission
- Device name
- Triage Panel for Drugs of Abuse/Tricyclic Antidepressants
- Applicant
- Biosite Incorporated
San Diego, CA, US - Received
- December 13, 1995
- Decision date
- February 15, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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| K062840 | Triage Protein C Controls and Calibration Verification ControlsGGN · Traditional | 03/01/2007SE |
| K062530 | Triage Protein C TestGGP · Traditional | 01/29/2007SE |
| K060788 | Triage Tox Drug Screen Control Level 1 Model 94413 and Level 2 Model 94414DIF · Traditional | 07/10/2006SE |
| K060791 | Triage Tox Drug Screen, Model 94400DJR · Traditional | 06/22/2006SE |
| K052789 | Triage BNP Test for Beckman Coulter Immunoassay Systems, Model 98200NBC · Traditional | 01/23/2006SE |
Questions and answers
When was Triage Panel for Drugs of Abuse/Tricyclic Antidepressants cleared by the FDA?
Triage Panel for Drugs of Abuse/Tricyclic Antidepressants (K955935) received a 510(k) decision of Substantially Equivalent on February 15, 1996, 64 days after the submission was received.
What is the product code of K955935?
The FDA product code is DKZ – Enzyme Immunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.