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510(k) K863489

PARAMAX ELECTROLYTE CALIBRATOR by American Dade — Product Code JIX

K863489 is an FDA 510(k) premarket notification submitted by American Dade for the device "PARAMAX ELECTROLYTE CALIBRATOR". The FDA issued a decision of Substantially Equivalent on September 29, 1986. The device falls under product code JIX (Calibrator, Multi-Analyte Mixture), a Class II device regulated under 21 CFR 862.1150. American Dade has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1986
Date Received
September 9, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Multi-Analyte Mixture
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

Other clearances by American Dade

  • K873051 — STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAY (October 20, 1987)
  • K873171 — STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY (September 29, 1987)
  • K873052 — STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAY (September 14, 1987)
  • K872789 — PARAMAX URINE/CSF CALIBRATOR (September 2, 1987)
  • K872195 — DATA-FI DIMERTEST LATEX ASSAY (August 6, 1987)
  • K872196 — AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III (July 31, 1987)
  • K871972 — STRATUS IGE FLUOROMETRIC ENZYME IMMUNOASSAY (July 21, 1987)
  • K871977 — DADE MONI-TROL CHEMISTRY CONTROL/CALIBRATOR (July 9, 1987)
  • K872050 — PARAMAX CHOLESTEROL REAGENT (July 7, 1987)
  • K872360 — DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SET (July 6, 1987)

Other clearances for product code JIX

  • K161140 — VITROS Chemistry Products Calibrator Kit 3 (May 20, 2016)
  • K153365 — ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator (December 18, 2015)
  • K151552 — ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech C (July 8, 2015)
  • K140790 — Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium F (June 15, 2015)
  • K141388 — SYSTEM CALIBRATER (July 11, 2014)
  • K133330 — C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PR (November 26, 2013)
  • K130765 — ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH C (April 4, 2013)
  • K123321 — DIMENSION CHEMISTRY III CALIBRATORY (February 15, 2013)
  • K123372 — ABBOTT LIPID MULTI CONSTITUENT CALIBRATOR (January 14, 2013)
  • K122398 — RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORS (October 12, 2012)

FDA data resources