SHOT-GUN ISOLAT PROCED/MEASUREMENT CK-MB IN SERUM— 510(k) K874284
Substantially EquivalentDiagnostic Chemicals, Ltd. (Usa)
FDA 510(k) clearance K874284 for SHOT-GUN ISOLAT PROCED/MEASUREMENT CK-MB IN SERUM, Substantially Equivalent on 1988-01-21. Applicant: Diagnostic Chemicals, Ltd. (Usa). Device class: 2.
Clearance details
- Applicant
- Diagnostic Chemicals, Ltd. (Usa)
- Product code
- Code JHT
- Device class
- Class 2
- Regulation
- 21 CFR 862.1215
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Monroe, CT, US
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- K904721 — DSL CK-MB (DSL #3200)
- K904866 — COULTER CK-MB ISOENZYME REAGENT
More clearances from Diagnostic Chemicals, Ltd. (Usa)
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