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510(k) K811025

AMES TDA TM PHENYTOIN TEST by Miles Laboratories, Inc. — Product Code LES

K811025 is an FDA 510(k) premarket notification submitted by Miles Laboratories, Inc. for the device "AMES TDA TM PHENYTOIN TEST". The FDA issued a decision of Substantially Equivalent on April 29, 1981. The device falls under product code LES (Fluorescent Immunoassay, Diphenylhydantoin), a Class II device regulated under 21 CFR 862.3350. Miles Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 1981
Date Received
April 16, 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 Miles Laboratories, Inc.

  • K880605 — LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTER (May 26, 1988)
  • K874909 — MICRO-BUMINTEST REAGENT TABLETS (April 28, 1988)
  • K875079 — MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULE (April 5, 1988)
  • K871835 — GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINT (December 22, 1987)
  • K872120 — SERALYZER III BLOOD CHEMISTRY ANALYZER (October 28, 1987)
  • K873304 — CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES) (September 11, 1987)
  • K872634 — CUTTER PUREFLO PLUS IV FILTER (August 4, 1987)
  • K870214 — MODIFIED SALTEX REAGENT STRIPS (June 29, 1987)
  • K870752 — SERALYZER LDH/TOTAL BILIRUBIN/TRIGLYCERIDES STRIPS (April 14, 1987)
  • K864530 — SERALYZER GLUCOSE (HK) REAGENT STRIPS,MODULE,CALI. (February 18, 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)
  • K831154 — STRATUS PHENYTOIN FLUOROMETRIC ENZYME (May 16, 1983)
  • K820187 — SYVA ADVANCE SYS. EMIT,(R)-AED(R) PHENY (February 12, 1982)
  • K813538 — PHENYTOIN FLUORESCENT IMMUNOASSAY (December 31, 1981)
  • K801736 — AMES TDA TM PHENYTOIN TEST (August 20, 1980)

FDA data resources