Benzodiazepines and Tricyclic Antidepressants by HPLC
FDA 510(k) K941994 · Bio-Rad
510(k) numberK941994
Submission
- Device name
- Benzodiazepines and Tricyclic Antidepressants by HPLC
- Applicant
- Bio-Rad
Hercules, CA, US - Received
- April 25, 1994
- Decision date
- March 20, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LFI – High Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3910
- Specialty
- Clinical Toxicology
Other 510(k)s with product code LFI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K941990 | Benozodiazepines and Tricylic Antidepressants by HPLCLFI · Traditional | Bio-Rad | 03/20/1995SE |
| K934340 | Biosite Diagnostics - Triage Panel for Drugs of Abuse Plus Tricyclic AntidepressantsLFI · Traditional | Biosite Incorporated | 12/02/1994SE |
| K802245 | 7 Tricyclic Antide PressantsLFI · Traditional | Technicon Instruments Corp. | 10/10/1980SE |
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Questions and answers
When was Benzodiazepines and Tricyclic Antidepressants by HPLC cleared by the FDA?
Benzodiazepines and Tricyclic Antidepressants by HPLC (K941994) received a 510(k) decision of Substantially Equivalent on March 20, 1995, 329 days after the submission was received.
What is the product code of K941994?
The FDA product code is LFI – High Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs, a Class II (moderate risk) device regulated under 21 CFR 862.3910.