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510(k) K821698

TDX NETILMICIN by Abbott Laboratories — Product Code LCE

K821698 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "TDX NETILMICIN". The FDA issued a decision of Substantially Equivalent on June 22, 1982. The device falls under product code LCE (Radioimmunoassay, Netilmicin (I-125)), a Class II device regulated under 21 CFR 862.3450. Abbott Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1982
Date Received
June 8, 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)
  • K822941 — NETILMICIN FLUORESCENT IMMUNOASSAY (October 26, 1982)
  • K821399 — MACRO-VUE CARD TEST, NETILMICIN (May 28, 1982)
  • K820324 — EMIT AND NETILMICIN ASSAY (February 23, 1982)

FDA data resources