510(k) K941994
- Device
- Benzodiazepines And Tricyclic Antidepressants By Hplc
- Applicant
- BIO-RAD
- 510(k) number
- K941994
- Product code
- LFI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-03-20
- Date received
- 1994-04-25
- Regulation
- 862.3910
- Classification name
- High Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs
- Medical specialty
- Clinical Toxicology
- Review panel
- Clinical Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOHN NELSON
- Address
- 4000 Alfred Nobel Dr. Hercules CA US 94547 94547
FDA Registration Numbers#
- 2246703
- 3004175381
- 2517506
- 1050155
- 3005174594
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LFI#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K941990 | BENOZODIAZEPINES AND TRICYLIC ANTIDEPRESSANTS BY HPLC | Bio-Rad | 1995-03-20 |
| K934340 | BIOSITE DIAGNOSTICS - TRIAGE PANEL FOR DRUGS OF ABUSE PLUS TRICYCLIC ANTIDEPRESSANTS | Biosite Incorporated | 1994-12-02 |
| K802245 | 7 TRICYCLIC ANTIDE PRESSANTS | Technicon Instruments Corp. | 1980-10-10 |