TIMENTIN 85MCG SENSITIVITY DISC
FDA 510(k) clearance K852423 · decided 1985-07-16
Clearance details
- K-number
- K852423
- Device name
- TIMENTIN 85MCG SENSITIVITY DISC
- Applicant
- Difco Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-06-07
- Decision date
- 1985-07-16
- Days to decision
- 39 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Detroit, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.