IL TEST(TM) PHENCYCLIDINE
FDA 510(k) clearance K913743 · decided 1991-11-07
Clearance details
- K-number
- K913743
- Device name
- IL TEST(TM) PHENCYCLIDINE
- Applicant
- Instrumentation Laboratory CO
- Decision
- Substantially Equivalent
- Date received
- 1991-08-20
- Decision date
- 1991-11-07
- Days to decision
- 79 days
- Clearance type
- Traditional
- Product code
- LCM
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Lexington, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.