BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6— 510(k) K050367
Substantially EquivalentHyphen Biomed
FDA 510(k) clearance K050367 for BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6, Substantially Equivalent on 2006-05-24. Applicant: Hyphen Biomed. Device class: 2.
Clearance details
- Applicant
- Hyphen Biomed
- Product code
- Code KFF
- Device class
- Class 2
- Regulation
- 21 CFR 864.7525
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mason, OH, US
Recent devices under product code KFF
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- K111822 — STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH
- K090209 — HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS
- K013305 — ENOXAPARIN TEST CARD
More clearances from Hyphen Biomed
view all- K071255 — ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A
- 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
- K043451 — BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIBRATOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.