BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH CALIBRATOR— 510(k) K051472
Substantially EquivalentHyphen Biomed
FDA 510(k) clearance K051472 for BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH CALIBRATOR, Substantially Equivalent on 2005-12-23. 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
- Traditional
- Location
- Mason, OH, US
Recent devices under product code GGN
view all- K170864 — VALIDATE D-Dimer Calibration Verification / Linearity Test Kit
- K163498 — VALIDATE Heparin Calibration Verification/Linearity Test Kit
- K161316 — George King Coumadin Plasma
- K162705 — VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit
- K152961 — VALIDATE D-Dimer Calibration Verification/Linearity Test Kit
More clearances from Hyphen Biomed
view all- K071255 — ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A
- K050367 — BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6
- K050365 — BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202
- K043007 — BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105
- K043451 — BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIBRATOR
Recalls naming K051472
K-number listed on FDA's recall record- Z-1743-2022 — BIOPHEN UFH Control Plasma
- Z-1188-2019 — BIOPHEN UFH Control C2, REF 223901
- Z-1189-2019 — BIOPHEN UFH Control C1, REF 224101
- Z-1190-2019 — BIOPHEN LMWH Control C4, REF 224201
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K051472.
Data sourced from openFDA. This site is unofficial and independent of the FDA.