AHLSTROM GRADE 226 SPECIMEN COLLECTION PAPER
FDA 510(k) clearance K062932 · decided 2007-10-19
Clearance details
- K-number
- K062932
- Device name
- AHLSTROM GRADE 226 SPECIMEN COLLECTION PAPER
- Applicant
- Ahlstrom Mount Holly Springs, LLC
- Decision
- Substantially Equivalent
- Date received
- 2006-09-28
- Decision date
- 2007-10-19
- Days to decision
- 386 days
- Clearance type
- Abbreviated
- Product code
- JKA
- Device class
- 2
- Regulation number
- 862.1675
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mount Holly Springs, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.