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510(k) K831154

STRATUS PHENYTOIN FLUOROMETRIC ENZYME by American Dade — Product Code LES

K831154 is an FDA 510(k) premarket notification submitted by American Dade for the device "STRATUS PHENYTOIN FLUOROMETRIC ENZYME". The FDA issued a decision of Substantially Equivalent on May 16, 1983. The device falls under product code LES (Fluorescent Immunoassay, Diphenylhydantoin), a Class II device regulated under 21 CFR 862.3350. American Dade has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 1983
Date Received
April 8, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorescent Immunoassay, Diphenylhydantoin
Device Class
Class II
Regulation Number
862.3350
Review Panel
TX
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 LES

  • K865102 — IMMPULSE COATED TUBE PHENYTOIN ASSAY REAGENTS (January 13, 1987)
  • K844990 — SYVA ADVANCE EMIT PHENYTOIN ASSAY (January 23, 1985)
  • K820187 — SYVA ADVANCE SYS. EMIT,(R)-AED(R) PHENY (February 12, 1982)
  • K813538 — PHENYTOIN FLUORESCENT IMMUNOASSAY (December 31, 1981)
  • K811025 — AMES TDA TM PHENYTOIN TEST (April 29, 1981)
  • K801736 — AMES TDA TM PHENYTOIN TEST (August 20, 1980)

FDA data resources