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510(k) K871972

STRATUS IGE FLUOROMETRIC ENZYME IMMUNOASSAY by American Dade — Product Code DGE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 1987
Date Received
May 21, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Igd, Rhodamine, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5510
Review Panel
IM
Submission Type

Other clearances by American Dade

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  • 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)
  • 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)
  • K870158 — STRATUS FREE THYROXINE (FT4) FLUOR. ENZYME IMMUNO. (March 19, 1987)

Other clearances for product code DGE

  • K915838 — OPUS FERRITIN TEST SYSTEM (March 18, 1992)