CALCITONIN 125— 510(k) K781909

Name: FDA 510(k) clearance K781909
Creator: U.S. Food and Drug Administration
Published: 1979-01-10

Substantially Equivalent

Cambridge Nuclear Radiopharmaceutical

FDA 510(k) clearance K781909 for CALCITONIN 125, Substantially Equivalent on 1979-01-10. Applicant: Cambridge Nuclear Radiopharmaceutical. Device class: 2.

Clearance details

Applicant: Cambridge Nuclear Radiopharmaceutical
Product code: Code JKR
Device class: Class 2
Regulation: 21 CFR 862.1140
Advisory panel: Clinical Chemistry
Date received: 1978-11-14
Decision date: 1979-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Recent devices under product code JKR

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K132828 — ELECSYS CALCITONIN; IMMUNOASSAY, CALSET, CALCHECK 5; ELECSYS PRECICONTROL VARIA 32013-12-04
K060578 — CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION)2006-08-30
K023304 — IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL2002-12-09

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