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510(k) K822941

NETILMICIN FLUORESCENT IMMUNOASSAY by American Diagnostic Corp. — Product Code LCE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 1982
Date Received
October 4, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Netilmicin (I-125)
Device Class
Class II
Regulation Number
862.3450
Review Panel
TX
Submission Type

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Other clearances for product code LCE

  • K833715 — EMIT NETILMICIN ASSAY (December 27, 1983)
  • K832088 — AMES TDA NETILMICIN TEST & SERUM (October 28, 1983)
  • K821698 — TDX NETILMICIN (June 22, 1982)
  • K821399 — MACRO-VUE CARD TEST, NETILMICIN (May 28, 1982)
  • K820324 — EMIT AND NETILMICIN ASSAY (February 23, 1982)