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510(k) K813148

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

K813148 is an FDA 510(k) premarket notification submitted by American Dade for the device "S/P VORTEX MIXER". The FDA issued a decision of Substantially Equivalent on November 24, 1981. The device falls under product code JRQ (Shaker/Stirrer), a Class I device regulated under 21 CFR 862.2050. American Dade has at least 10 other 510(k) clearances on record.

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

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 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)

FDA data resources