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510(k) K832769

AMES TDA KANAMYCIN TEST-CONTROL SERUM by Miles Laboratories, Inc. — Product Code KJI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1983
Date Received
August 16, 1983
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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  • 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 KJI

  • 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)
  • K772038 — KANAMYCIN RIA (January 12, 1978)