BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105— 510(k) K043007
Substantially EquivalentHyphen Biomed
FDA 510(k) clearance K043007 for BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105, Substantially Equivalent on 2005-11-07. Applicant: Hyphen Biomed. Device class: 2.
Clearance details
- Applicant
- Hyphen Biomed
- Product code
- Code JBQ
- Device class
- Class 2
- Regulation
- 21 CFR 864.7060
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mason, OH, US
Recent devices under product code JBQ
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- K051472 — BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH CALIBRATOR
- K043451 — BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIBRATOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.