ESKACHEM, CK-MB REAGENT— 510(k) K792023
Substantially EquivalentSmithkline Diagnostics, Inc.
FDA 510(k) clearance K792023 for ESKACHEM, CK-MB REAGENT, Substantially Equivalent on 1979-10-30. Applicant: Smithkline Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Smithkline Diagnostics, Inc.
- Product code
- Code JHS
- Device class
- Class 2
- Regulation
- 21 CFR 862.1215
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code JHS
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