SURE COUNT 5 & 10 SPONGE COUNTER
FDA 510(k) clearance K853454 · decided 1985-09-05
Clearance details
- K-number
- K853454
- Device name
- SURE COUNT 5 & 10 SPONGE COUNTER
- Applicant
- Kleen Test Products
- Decision
- Substantially Equivalent
- Date received
- 1985-08-16
- Decision date
- 1985-09-05
- Days to decision
- 20 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Milwaukee, WI, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Kleen Test Products
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Recalls involving this device
No recalls on record reference this clearance.