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510(k) K772038

KANAMYCIN RIA by Monitor Science Corp. — Product Code KJI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 1978
Date Received
October 28, 1977
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

Other clearances by Monitor Science Corp.

  • K790580 — RIA KIT, PROSTATIC ACID (May 25, 1979)
  • K780949 — BIO-MONITOR AMIKACIN (August 14, 1978)
  • K780950 — BIO-MONITOR TOBRAMYCIN (August 14, 1978)
  • K780951 — BIO-MONITOR GENTAMICIN (August 14, 1978)
  • K772039 — BETA-HCG RIA (November 23, 1977)

Other clearances for product code KJI

  • K832769 — AMES TDA KANAMYCIN TEST-CONTROL SERUM (September 29, 1983)
  • K823370 — ADVANCE TM EMIT(R) & TM AMIKACIN ASSAY (December 3, 1982)
  • K823062 — KENAMYCIN FLUORESCENT IMMUNOASSAY FIA (November 10, 1982)
  • K822808 — TDX KENAMYCIN (October 8, 1982)
  • K782125 — RIA KIT, KANAMYCIN (January 10, 1979)