Proteinmeter

FDA 510(k) K863112 · J. D. Assoc.

Substantially Equivalent

510(k) numberK863112

Submission

Device name
Proteinmeter
Applicant
J. D. Assoc.
Montclair, NJ, US
Received
August 13, 1986
Decision date
December 10, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JGP – Lowry (Colorimetric), Total Protein
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1635
Specialty
Clinical Chemistry

Other 510(k)s with product code JGP

510(k)DeviceApplicantDecision
K070757Microprotein Reagent SetJGP · Traditional Pointe Scientific, Inc.,12/04/2007SE
K964960Vitros Chemistry Products Upro SlidesJGP · Traditional Johnson & Johnson Clinical Diagnostics, Inc.02/18/1997SE
K821534Hematology Data Management SysJGP · Traditional Biovation, Inc.06/10/1982SE
K792347Micro Lowry ProteintestJGP · Traditional Panmed, Inc.12/06/1979SE

More from Panmed, Inc.

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
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
K863056Bilirubin TotalCIG · Traditional 11/24/1986SE

Questions and answers

When was Proteinmeter cleared by the FDA?

Proteinmeter (K863112) received a 510(k) decision of Substantially Equivalent on December 10, 1986, 119 days after the submission was received.

What is the product code of K863112?

The FDA product code is JGP – Lowry (Colorimetric), Total Protein, a Class II (moderate risk) device regulated under 21 CFR 862.1635.