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510(k) K820324

EMIT AND NETILMICIN ASSAY by Syva Co. — Product Code LCE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 1982
Date Received
February 5, 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

Other clearances by Syva Co.

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  • K011947 — EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL (July 2, 2001)
  • K011528 — EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229 (June 6, 2001)
  • K011347 — EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229 (May 17, 2001)
  • K993981 — SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL (February 1, 2000)
  • K993980 — SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL (February 1, 2000)
  • K993029 — ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS; MODELS 1E09 AND 6E89 (January 27, 2000)
  • 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 LCE

  • K833715 — EMIT NETILMICIN ASSAY (December 27, 1983)
  • K832088 — AMES TDA NETILMICIN TEST & SERUM (October 28, 1983)
  • K822941 — NETILMICIN FLUORESCENT IMMUNOASSAY (October 26, 1982)
  • K821698 — TDX NETILMICIN (June 22, 1982)
  • K821399 — MACRO-VUE CARD TEST, NETILMICIN (May 28, 1982)