SURE-COUNT 15 COUNT NEEDLE COUNTER
FDA 510(k) clearance K852257 · decided 1985-06-26
Clearance details
- K-number
- K852257
- Device name
- SURE-COUNT 15 COUNT NEEDLE COUNTER
- Applicant
- Kleen Test Products
- Decision
- Substantially Equivalent
- Date received
- 1985-05-24
- Decision date
- 1985-06-26
- Days to decision
- 33 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Milwaukee, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.