THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY— 510(k) K041502
Substantially EquivalentHaemoscope Corp.
FDA 510(k) clearance K041502 for THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY, Substantially Equivalent on 2004-09-01. Applicant: Haemoscope Corp.. Device class: 2.
Clearance details
- Applicant
- Haemoscope Corp.
- Product code
- Code JOZ
- Device class
- Class 2
- Regulation
- 21 CFR 864.5700
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Niles, IL, US
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More clearances from Haemoscope Corp.
view allRecalls naming K041502
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K041502.
Data sourced from openFDA. This site is unofficial and independent of the FDA.