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510(k) K813148

S/P VORTEX MIXER by American Dade — Product Code JRQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 1981
Date Received
November 6, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shaker/Stirrer
Device Class
Class I
Regulation Number
862.2050
Review Panel
CH
Submission Type

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  • 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 JRQ

  • K813318 — MINI-SHAKER (December 17, 1981)
  • K813149 — S/P VORTEX MIXER JR. (November 24, 1981)
  • K801145 — SMI MULTI-TUBE VORTEXER (June 9, 1980)
  • K790753 — DIMENSIONALL ROTATOR (June 28, 1979)
  • K790027 — SHAKER, MODEL SH-510 (February 8, 1979)
  • K780543 — THERMAJUST CIRCU-TEMP (May 26, 1978)
  • K770165 — MICRO-MIX PIPETTE SHAKER (January 31, 1977)