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510(k) K833715

EMIT NETILMICIN ASSAY by Syva Co. — Product Code LCE

K833715 is an FDA 510(k) premarket notification submitted by Syva Co. for the device "EMIT NETILMICIN ASSAY". The FDA issued a decision of Substantially Equivalent on December 27, 1983. The device falls under product code LCE (Radioimmunoassay, Netilmicin (I-125)), a Class II device regulated under 21 CFR 862.3450. Syva Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 1983
Date Received
October 21, 1983
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.

  • K011878 — EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRA (August 13, 2001)
  • K012257 — EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229 (August 3, 2001)
  • 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)
  • K993980 — SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL (February 1, 2000)
  • K993981 — SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL (February 1, 2000)
  • K993985 — SYVA EMIT II PLUS BENZODIAZEPINE ASSAY, MODELS 9F029UL/9F129UL (January 27, 2000)
  • K993031 — ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS;MODELS 1E08 AND 5F54 (January 27, 2000)
  • K993982 — SYVA EMIT II PLUS AMPHETAMINE/METHAMPHETAMINE ASSAY 9C029UL/9C129UL (January 27, 2000)

Other clearances for product code LCE

  • 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)
  • K820324 — EMIT AND NETILMICIN ASSAY (February 23, 1982)

FDA data resources