HEMAWIPE SYSTEM, THE CIVILIZED TEST— 510(k) K884206
Substantially EquivalentLabeltape Meditect, Inc.
FDA 510(k) clearance K884206 for HEMAWIPE SYSTEM, THE CIVILIZED TEST, Substantially Equivalent on 1989-04-18. 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.