BIOSITE DIAGNOSTICS - TRIAGE PANEL FOR DRUGS OF ABUSE PLUS TRICYCLIC ANTIDEPRESSANTS
FDA 510(k) clearance K934340 · decided 1994-12-02
Clearance details
- K-number
- K934340
- Device name
- BIOSITE DIAGNOSTICS - TRIAGE PANEL FOR DRUGS OF ABUSE PLUS TRICYCLIC ANTIDEPRESSANTS
- Applicant
- Biosite Incorporated
- Decision
- Substantially Equivalent
- Date received
- 1993-09-08
- Decision date
- 1994-12-02
- Days to decision
- 450 days
- Clearance type
- Traditional
- Product code
- LFI
- Device class
- 2
- Regulation number
- 862.3910
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Biosite Incorporated
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BENOZODIAZEPINES AND TRICYLIC ANTIDEPRESSANTS BY HPLC (K941990) | Bio-Rad | 1995-03-20 |
| BENZODIAZEPINES AND TRICYCLIC ANTIDEPRESSANTS BY HPLC (K941994) | Bio-Rad | 1995-03-20 |
| 7 TRICYCLIC ANTIDE PRESSANTS (K802245) | Technicon Instruments Corp. | 1980-10-10 |
Recalls involving this device
No recalls on record reference this clearance.