CALCITONIN— 510(k) K990073
Substantially EquivalentKmi Diagnostics, Inc.
FDA 510(k) clearance K990073 for CALCITONIN, Substantially Equivalent on 1999-05-11. Applicant: Kmi Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Kmi Diagnostics, Inc.
- Product code
- Code JKR
- Device class
- Class 2
- Regulation
- 21 CFR 862.1140
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Osceola, WI, US
Recent devices under product code JKR
view all- K252431 — Elecsys Calcitonin
- K182012 — ADVIA Centaur Calcitonin (CALCT) assay
- K132828 — ELECSYS CALCITONIN; IMMUNOASSAY, CALSET, CALCHECK 5; ELECSYS PRECICONTROL VARIA 3
- K060578 — CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION)
- K023304 — IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL
More clearances from Kmi Diagnostics, Inc.
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