BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIBRATOR— 510(k) K043451
Substantially EquivalentHyphen Biomed
FDA 510(k) clearance K043451 for BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIBRATOR, Substantially Equivalent on 2005-03-17. Applicant: Hyphen Biomed. Device class: 2.
Clearance details
- Applicant
- Hyphen Biomed
- Product code
- Code GGN
- Device class
- Class 2
- Regulation
- 21 CFR 864.5425
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Mason, OH, US
Recent devices under product code GGN
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- K162705 — VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit
- K152961 — VALIDATE D-Dimer Calibration Verification/Linearity Test Kit
More clearances from Hyphen Biomed
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- K050367 — BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6
- K050365 — BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202
- K051472 — BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH CALIBRATOR
- K043007 — BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105
Data sourced from openFDA. This site is unofficial and independent of the FDA.