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510(k) K823370

ADVANCE TM EMIT(R) & TM AMIKACIN ASSAY by Syva Co. — Product Code KJI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 1982
Date Received
November 10, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Kanamycin
Device Class
Class II
Regulation Number
862.3520
Review Panel
TX
Submission Type

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  • K993983 — SYVA EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL 9J029UL (January 27, 2000)
  • K993986 — SYVA EMIT II PLUS METHAQUALONE ASSAY, MODEL 9Q029UL/9Q129UL (January 27, 2000)

Other clearances for product code KJI

  • K832769 — AMES TDA KANAMYCIN TEST-CONTROL SERUM (September 29, 1983)
  • K823062 — KENAMYCIN FLUORESCENT IMMUNOASSAY FIA (November 10, 1982)
  • K822808 — TDX KENAMYCIN (October 8, 1982)
  • K782125 — RIA KIT, KANAMYCIN (January 10, 1979)
  • K772038 — KANAMYCIN RIA (January 12, 1978)