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510(k) K820187

SYVA ADVANCE SYS. EMIT,(R)-AED(R) PHENY by Syva Co. — Product Code LES

K820187 is an FDA 510(k) premarket notification submitted by Syva Co. for the device "SYVA ADVANCE SYS. EMIT,(R)-AED(R) PHENY". The FDA issued a decision of Substantially Equivalent on February 12, 1982. The device falls under product code LES (Fluorescent Immunoassay, Diphenylhydantoin), a Class II device regulated under 21 CFR 862.3350. Syva Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 1982
Date Received
January 25, 1982
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 Syva Co.

  • K011878 — EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRA (August 13, 2001)
  • K012257 — EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229 (August 3, 2001)
  • K011947 — EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL (July 2, 2001)
  • K011528 — EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229 (June 6, 2001)
  • K011347 — EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229 (May 17, 2001)
  • K993980 — SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL (February 1, 2000)
  • K993981 — SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL (February 1, 2000)
  • K993029 — ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS; MODELS 1E09 AND 6E89 (January 27, 2000)
  • K993985 — SYVA EMIT II PLUS BENZODIAZEPINE ASSAY, MODELS 9F029UL/9F129UL (January 27, 2000)
  • K993988 — SYVA EMIT II PLUS COCAINE METABOLITE ASSAY, MODEL 9H029UL (January 27, 2000)

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)
  • 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