CORNING CALCIUM PH ANALYZER 634

K844188 · Corning Medical & Scientific · JFP · Feb 4, 1985 · Clinical Chemistry

Device Facts

Record IDK844188
Device NameCORNING CALCIUM PH ANALYZER 634
ApplicantCorning Medical & Scientific
Product CodeJFP · Clinical Chemistry
Decision DateFeb 4, 1985
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 862.1145
Device ClassClass 2

Regulatory Classification

Identification

A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

Innolitics
510(k) Summary
Decision Summary
Classification Order
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