LASER-CAL— 510(k) K811063
Substantially EquivalentDiagnostic Technology, Inc.
FDA 510(k) clearance K811063 for LASER-CAL, Substantially Equivalent on 1981-07-01. Applicant: Diagnostic Technology, Inc.. Device class: 2.
Clearance details
- Applicant
- Diagnostic Technology, Inc.
- Product code
- Code KRX
- Device class
- Class 2
- Regulation
- 21 CFR 864.8150
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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