ROTASCREEN
FDA 510(k) clearance K872568 · decided 1987-09-14
Clearance details
- K-number
- K872568
- Device name
- ROTASCREEN
- Applicant
- Mercia Diagnostics , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1987-06-29
- Decision date
- 1987-09-14
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- GOB
- Device class
- 1
- Regulation number
- 866.3020
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Guildford, Surrey England, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.