QUANTECH CK-MB ASSAY— 510(k) K984433
Substantially EquivalentQuantech , Ltd.
FDA 510(k) clearance K984433 for QUANTECH CK-MB ASSAY, Substantially Equivalent on 1999-11-01. Applicant: Quantech , Ltd.. Device class: 2.
Clearance details
- Applicant
- Quantech , Ltd.
- Product code
- Code MYT
- Device class
- Class 2
- Regulation
- 21 CFR 862.1215
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Northridge, CA, US
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