DISPENS-O-DISC PIPERACILLIN 100 MCG./TAZOBACTAM 10 MCG.
FDA 510(k) clearance K944275 · decided 1994-12-19
Clearance details
- K-number
- K944275
- Device name
- DISPENS-O-DISC PIPERACILLIN 100 MCG./TAZOBACTAM 10 MCG.
- Applicant
- Difco Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-08-30
- Decision date
- 1994-12-19
- Days to decision
- 111 days
- Clearance type
- Traditional
- Product code
- JTN
- Device class
- 2
- Regulation number
- 866.1620
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- 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.