Calibrator II

FDA 510(k) K791694 · Hi Chem, Inc.

Substantially Equivalent

510(k) numberK791694

Submission

Device name
Calibrator II
Applicant
Hi Chem, Inc.
Mchenry, IL, US
Received
July 31, 1979
Decision date
September 17, 1979
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JIX – Calibrator, Multi-Analyte Mixture
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1150
Specialty
Clinical Chemistry

Other 510(k)s with product code JIX

510(k)DeviceApplicantDecision
K161140VITROS Chemistry Products Calibrator Kit 3JIX · Abbreviated Ortho-Clinical Diagnostics, Inc.05/20/2016SE
K153365ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 CalibratorJIX · Traditional Siemens Healthcare Diagnostics, Inc.12/18/2015SE
K151552ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical…JIX · Abbreviated Elitechgroup07/08/2015SE
K140790Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex…JIX · Traditional Siemens Healthcare Diagnostics06/15/2015SE
K141388System CalibraterJIX · Abbreviated Beckman Coulter Ireland, Inc.07/11/2014SE
K133330C.F.A.S. Proteins, C.F.A.S. Pac, Precicontrol Clinchem Multi 1 & 2, Precinorm Protein &…JIX · Special Roche Diagnostics11/26/2013SE
K130765Elitech Clinical Systems Elical 2; Elitech Clinical Systems Elitrol I, Elitech Clinical…JIX · Abbreviated Elitechgroup04/04/2013SE
K123321Dimension Chemistry III CalibratoryJIX · Traditional Siemens Healthcare Diagnostics02/15/2013SE
K123372Abbott Lipid Multi Constituent CalibratorJIX · Traditional Abbott Laboratories01/14/2013SE
K122398Rapidpoint 500 System Measurement Cartridge with CalibratorsJIX · Traditional Siemens Healthcare Diagnostics, Inc.10/12/2012SE

More from Siemens Healthcare Diagnostics, Inc.

510(k)DeviceDecision
K960084Hichem Glucose/Hk Reagent KitCFR · Traditional 04/04/1996SE
K951818Hichem Alt Reagent KitCKA · Traditional 05/15/1995SE
K943684Hichem Enzyme Verifier KitJJT · Traditional 10/04/1994SE
K941764Hichem Calcium Reagent for the Synchron CX3 Prod. No. 88808CJY · Traditional 05/13/1994SE
K902673Hi Chem Total Protein/Albumin Serum Range Lin STNDJJY · Traditional 07/17/1990SE
K863617Ion 2/4 Flow Cell Cleaner (Product #88656)JGS · Traditional 10/24/1986SE
K862027LDP Reagent Cartridge (No. 88216)CFJ · Traditional 06/13/1986SE
K861893GGT Reagent Cartridge (Product No. 88204)JXL · Traditional 06/05/1986SE
K861879CK Reagent Cartridge (Product No. 88213)CGS · Traditional 05/29/1986SE
K861419Hi Chem Diagnostics LDL Reagent CartridgeCFJ · Traditional 04/28/1986SE

Questions and answers

When was Calibrator II cleared by the FDA?

Calibrator II (K791694) received a 510(k) decision of Substantially Equivalent on September 17, 1979, 48 days after the submission was received.

What is the product code of K791694?

The FDA product code is JIX – Calibrator, Multi-Analyte Mixture, a Class II (moderate risk) device regulated under 21 CFR 862.1150.