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510(k) K820130

ADVANCE SYSTEM EMIT-AMD TOBRAMYCIN ASSAY by Syva Co. — Product Code LCR

K820130 is an FDA 510(k) premarket notification submitted by Syva Co. for the device "ADVANCE SYSTEM EMIT-AMD TOBRAMYCIN ASSAY". The FDA issued a decision of Substantially Equivalent on February 5, 1982. The device falls under product code LCR (Fluorescent Immunoassay, Tobramycin), a Class II device regulated under 21 CFR 862.3900. Syva Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 1982
Date Received
January 18, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorescent Immunoassay, Tobramycin
Device Class
Class II
Regulation Number
862.3900
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)
  • K993029 — ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS; MODELS 1E09 AND 6E89 (January 27, 2000)
  • K993988 — SYVA EMIT II PLUS COCAINE METABOLITE ASSAY, MODEL 9H029UL (January 27, 2000)
  • K993031 — ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS;MODELS 1E08 AND 5F54 (January 27, 2000)

Other clearances for product code LCR

  • K060998 — QMS TOBRAMYCIN (July 21, 2006)
  • K974029 — ACS TOBRAMYCIN (February 12, 1998)
  • K962818 — TOBRAMYCIN FLEX REAGENT CARTRIDGE (September 13, 1996)
  • K952568 — BECKMAN ARRAY TOBRAMYCIN (TOB) REAGENT (August 8, 1995)
  • K911940 — OPUS(R) TOBRAMYCIN (July 1, 1991)
  • K911613 — VAR AURAL GROM AG/S9,SD8.00.28.5/0.2 NS/S/6823 1.4 (June 28, 1991)
  • K854873 — INTRAOCULAR PRESSURE REDUCER (February 4, 1986)
  • K850058 — DU PONT TOBRAMYCIN ASSAY REAGENTS (January 18, 1985)
  • K840847 — IMMPULSE TOBRAMYCIN ASSAY REAGENTS (April 4, 1984)
  • K832408 — STRATUS TOBRAMYCIN FLUOROMETRIC ENZYM (August 26, 1983)

FDA data resources