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510(k) K823368

DADE ESR KIT by American Dade — Product Code JPH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 28, 1982
Date Received
November 10, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Erythrocyte Sedimentation Rate
Device Class
Class I
Regulation Number
864.6700
Review Panel
HE
Submission Type

Other clearances by American Dade

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  • 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 JPH

  • K871076 — WINPETTE (March 23, 1987)
  • K860899 — DISPETTE II (April 14, 1986)
  • K852554 — SRT-SYSTEM (July 18, 1985)
  • K840500 — SEDIPLAST (February 21, 1984)
  • K831195 — WESTERGREN DISPETTE FOR ESR (May 9, 1983)
  • K823761 — ERYTHROCYTE & STAND SEDIMENT. RATE TUBE (January 21, 1983)