STREPTOMYCIN DISK (300MCG)
FDA 510(k) clearance K961819 · decided 1996-07-10
Clearance details
- K-number
- K961819
- Device name
- STREPTOMYCIN DISK (300MCG)
- Applicant
- Remel, L.P.
- Decision
- Substantially Equivalent
- Date received
- 1996-05-10
- Decision date
- 1996-07-10
- Days to decision
- 61 days
- Clearance type
- Traditional
- Product code
- JTN
- Device class
- 2
- Regulation number
- 866.1620
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Lenexa, KS, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.