POLYMEDCO OC AUTO MICRO 80 FOB TEST— 510(k) K041408
Substantially EquivalentPolymedco, Inc.
FDA 510(k) clearance K041408 for POLYMEDCO OC AUTO MICRO 80 FOB TEST, Substantially Equivalent on 2004-10-21. Applicant: Polymedco, Inc.. Device class: 2.
Clearance details
- Applicant
- Polymedco, Inc.
- Product code
- Code OOX
- Device class
- Class 2
- Regulation
- 21 CFR 864.6550
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cortlandt Manor, NY, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.