Para-Fix C&S Medium
FDA 510(k) clearance K150887 · decided 2015-05-29
Clearance details
- K-number
- K150887
- Device name
- Para-Fix C&S Medium
- Applicant
- Medical Chemical Corporation
- Decision
- Substantially Equivalent
- Date received
- 2015-04-02
- Decision date
- 2015-05-29
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- JSM
- Device class
- 1
- Regulation number
- 866.2390
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Torrance, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.