Ionometer Ef and Accessories

FDA 510(k) K870183 · Smash Ent., Inc.

Substantially Equivalent

510(k) numberK870183

Submission

Device name
Ionometer Ef and Accessories
Applicant
Smash Ent., Inc.
Shoreview, MN, US
Received
January 16, 1987
Decision date
May 12, 1987
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JGS – Electrode, Ion Specific, Sodium
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1665
Specialty
Clinical Chemistry

Other 510(k)s with product code JGS

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K222438A-LYTE® Integrated Multisensor (IMT Na K Cl)JGS · Traditional Siemens Healthcare Diagnostics, Inc.07/25/2023SE
K220977ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry AnalyzerJGS · Traditional Beckman Coulter Laboratory Systems (Suzhou) Co.…07/20/2023SE
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K200403Stat Profile Prime Plus Analyzer SystemJGS · Traditional Nova Biomedical Corporation04/14/2020SE
K183688i-STAT CHEM8+ cartridge with the i-STAT 1 SystemJGS · Traditional Abbott Point of Care, Inc.02/07/2020SE
K191365Stat Profile Prime ES Comp Plus Analyzer SystemJGS · Traditional Nova Biomedical Corporation07/19/2019SE
K172232LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600JGS · Traditional Ams Diagnostics06/12/2019SE
K183549GEM Premier ChemSTATJGS · Traditional Instrumentation Laboratory CO02/16/2019SE

More from Instrumentation Laboratory CO

510(k)DeviceDecision
K880857Syringe Pump MS2000FRN · Traditional 09/01/1988SE
K881162Entera* Enteral Feeding BagKNT · Traditional 06/03/1988SE
K880373Ionometer E-Hk and AccessoriesGKF · Traditional 03/17/1988SE

Questions and answers

When was Ionometer Ef and Accessories cleared by the FDA?

Ionometer Ef and Accessories (K870183) received a 510(k) decision of Substantially Equivalent on May 12, 1987, 116 days after the submission was received.

What is the product code of K870183?

The FDA product code is JGS – Electrode, Ion Specific, Sodium, a Class II (moderate risk) device regulated under 21 CFR 862.1665.