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510(k) K871972

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

K871972 is an FDA 510(k) premarket notification submitted by American Dade for the device "STRATUS IGE FLUOROMETRIC ENZYME IMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on July 21, 1987. The device falls under product code DGE (Igd, Rhodamine, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5510. American Dade has at least 10 other 510(k) clearances on record.

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

  • 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)
  • 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)

FDA data resources