Ionized Calcium and Blood PH Testcards

FDA 510(k) K860639 · Ilex Corp.

Substantially Equivalent

510(k) numberK860639

Submission

Device name
Ionized Calcium and Blood PH Testcards
Applicant
Ilex Corp.
Attleboro, MA, US
Received
February 20, 1986
Decision date
April 21, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JFP – Electrode, Ion Specific, Calcium
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1145
Specialty
Clinical Chemistry

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K963694Easylyte Calcium/Chloride AnalyzerJFP · Traditional Medica Corp.11/27/1996SE
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K960120Stat Profile Ultra F,G,H,I,J, and K AnalyzersJFP · Traditional Nova Biomedical Corp.03/11/1996SE
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More from Medica Corp.

510(k)DeviceDecision
K860543Blood Urea Nitrogen (Bun) TestcardCDS · Traditional 04/21/1986SE
K853068Ilex Prompt Clinical Chemistry AnalyerCEM · Traditional 10/31/1985SE

Questions and answers

When was Ionized Calcium and Blood PH Testcards cleared by the FDA?

Ionized Calcium and Blood PH Testcards (K860639) received a 510(k) decision of Substantially Equivalent on April 21, 1986, 60 days after the submission was received.

What is the product code of K860639?

The FDA product code is JFP – Electrode, Ion Specific, Calcium, a Class II (moderate risk) device regulated under 21 CFR 862.1145.