HEMAWIPE SYSTEM, THE CIVILIZED TEST, MODIFICATION— 510(k) K912979
Substantially EquivalentLabeltape Meditect, Inc.
FDA 510(k) clearance K912979 for HEMAWIPE SYSTEM, THE CIVILIZED TEST, MODIFICATION, Substantially Equivalent on 1991-10-04. Applicant: Labeltape Meditect, Inc.. Device class: 2.
Clearance details
- Applicant
- Labeltape Meditect, Inc.
- Product code
- Code KHE
- Device class
- Class 2
- Regulation
- 21 CFR 864.6550
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Grand Rapids, MI, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.