QUANTIMETRIC 2 TEST KIT— 510(k) K813242
Substantially EquivalentKallestad Laboratories, Inc.
FDA 510(k) clearance K813242 for QUANTIMETRIC 2 TEST KIT, Substantially Equivalent on 1981-12-02. Applicant: Kallestad Laboratories, Inc.. Device class: 1.
Clearance details
- Applicant
- Kallestad Laboratories, Inc.
- Product code
- Code KEW
- Device class
- Class 1
- Regulation
- 21 CFR 864.3010
- Advisory panel
- Pathology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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