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510(k) K813538

PHENYTOIN FLUORESCENT IMMUNOASSAY by American Diagnostic Corp. — Product Code LES

K813538 is an FDA 510(k) premarket notification submitted by American Diagnostic Corp. for the device "PHENYTOIN FLUORESCENT IMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on December 31, 1981. The device falls under product code LES (Fluorescent Immunoassay, Diphenylhydantoin), a Class II device regulated under 21 CFR 862.3350. American Diagnostic Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 31, 1981
Date Received
December 21, 1981
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 Diagnostic Corp.

  • K162589 — Adscope 658 Electronic Stethoscope (March 10, 2017)
  • K093495 — OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS (November 19, 2010)
  • K060321 — ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BK (May 15, 2006)
  • K012304 — ADC 656 ELECTRONIC STETHOSCOPE (November 1, 2001)
  • K962655 — ANEROID AND MERCURIAL SPHYGMOMANOMETERS (January 27, 1997)
  • K940686 — ELECTRONIC THERMOMETERS (July 8, 1994)
  • K935944 — PROSCOPES AND ADSCOPES (March 3, 1994)
  • K932145 — COAGULATION REFERENCE PLASMA, NORMAL (October 18, 1993)
  • K894169 — BIOTEL MICROALBUMINURIA (TM) (September 18, 1989)
  • K893608 — ACTICHROME ATIII KIT (June 23, 1989)

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)
  • K831154 — STRATUS PHENYTOIN FLUOROMETRIC ENZYME (May 16, 1983)
  • K820187 — SYVA ADVANCE SYS. EMIT,(R)-AED(R) PHENY (February 12, 1982)
  • K811025 — AMES TDA TM PHENYTOIN TEST (April 29, 1981)
  • K801736 — AMES TDA TM PHENYTOIN TEST (August 20, 1980)

FDA data resources