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510(k) K871182

FLAME PHOTOMETER STANDARD #60081 120 NA/2K by In Vitro Diagnostics, Inc. — Product Code JIX

K871182 is an FDA 510(k) premarket notification submitted by In Vitro Diagnostics, Inc. for the device "FLAME PHOTOMETER STANDARD #60081 120 NA/2K". The FDA issued a decision of Substantially Equivalent on May 28, 1987. The device falls under product code JIX (Calibrator, Multi-Analyte Mixture), a Class II device regulated under 21 CFR 862.1150. In Vitro Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 1987
Date Received
March 24, 1987
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 In Vitro Diagnostics, Inc.

  • K896867 — THYROID STIMULATING HORMONE-EIA-XT (February 23, 1990)
  • K896866 — LUTEINIZING HORMONE-EIA-XT (February 13, 1990)
  • K896863 — DIGOXIN-EIA-XT (February 13, 1990)
  • K896865 — VITRO T4-EIA-XT (January 30, 1990)
  • K896925 — T UPTAKE ENZYME IMMUNOASSAY CRIMPED TUBE KIT (January 18, 1990)
  • K896864 — FOLLICLE STIMULATING HORMONE-EIA-XT (January 11, 1990)
  • K873832 — REAGENTS FOR USE ON CONTRAVES DC300, DC500, AL801 (November 23, 1987)
  • K871184 — FLAME PHOTOMETER STANDARD #60083 160 NA/8K (May 28, 1987)
  • K871186 — CESIUM DILUENT 1.5 MMOL CS/L #60087 (May 28, 1987)
  • K871188 — LITHIUM INTERNAL STANDARD 1500 MEQ/L #60086 (May 28, 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