Calciometer

FDA 510(k) K863059 · J. D. Assoc.

Substantially Equivalent

510(k) numberK863059

Submission

Device name
Calciometer
Applicant
J. D. Assoc.
Montclair, NJ, US
Received
August 12, 1986
Decision date
September 26, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
CIA – Methylthymol Blue, Calcium
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1145
Specialty
Clinical Chemistry

Other 510(k)s with product code CIA

510(k)DeviceApplicantDecision
K870369Calcium Reagent-Methyl Thymol Blue MethodCIA · Traditional Trace Scientific , Ltd.08/19/1987SE
K822898DSL 1600CIA · Traditional Diagnostic Systems Laboratories, Inc.12/09/1982SE
K792396Elvi CalciumCIA · Traditional Volu Sol Medical Industries12/06/1979SE
K771468Multistat III Calcium TestCIA · Traditional Instrumentation Laboratory CO09/12/1977SE

More from Instrumentation Laboratory CO

510(k)DeviceDecision
K863103Peg 6,000CHH · Traditional 01/13/1987SE
K863054Ast S.C.E. (Got)CIT · Traditional 01/13/1987SE
K863069MagnesiometerJGJ · Traditional 12/31/1986SE
K863079CreatinkineticCGX · Traditional 12/12/1986SE
K863112ProteinmeterJGP · Traditional 12/10/1986SE
K863068LDH S.C.E.CFJ · Traditional 12/10/1986SE
K863053Alt S.C.E. (GPT)CKA · Traditional 12/10/1986SE
K863066TransfermeterJQF · Traditional 12/04/1986SE
K863109FerrofastJIY · Traditional 11/24/1986SE
K863102Glucometer-ECGA · Traditional 11/24/1986SE

Questions and answers

When was Calciometer cleared by the FDA?

Calciometer (K863059) received a 510(k) decision of Substantially Equivalent on September 26, 1986, 45 days after the submission was received.

What is the product code of K863059?

The FDA product code is CIA – Methylthymol Blue, Calcium, a Class II (moderate risk) device regulated under 21 CFR 862.1145.