LUMI-AGGREGOMETER— 510(k) K771198
Substantially EquivalentChrono-Log Corp.
FDA 510(k) clearance K771198 for LUMI-AGGREGOMETER, Substantially Equivalent on 1977-08-02. Applicant: Chrono-Log Corp.. Device class: 2.
Clearance details
- Applicant
- Chrono-Log Corp.
- Product code
- Code JBY
- Device class
- Class 2
- Regulation
- 21 CFR 864.6675
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Havertown, PA, US
Recent devices under product code JBY
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- K962426 — CHRONO-LOG WHOLE BLOOD AGGREGOMETER (WBA) 591/592
- K945414 — RISTOCETIN COFACTOR ASSAY KIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.