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510(k) K060998

QMS TOBRAMYCIN by Seradyn, Inc. — Product Code LCR

K060998 is an FDA 510(k) premarket notification submitted by Seradyn, Inc. for the device "QMS TOBRAMYCIN". The FDA issued a decision of Substantially Equivalent on July 21, 2006. The device falls under product code LCR (Fluorescent Immunoassay, Tobramycin), a Class II device regulated under 21 CFR 862.3900. Seradyn, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 2006
Date Received
April 11, 2006
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 Seradyn, Inc.

  • K070645 — SERADYN QMS TOPIRAMATE (May 17, 2007)
  • K062966 — QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLS (January 12, 2007)
  • K062204 — ARCHITECT CORTISOL ASSAY (September 22, 2006)
  • K060709 — MULTIGENT GENTAMICIN (June 15, 2006)
  • K052826 — QMS QUINIDINE. QMS QUINIDINE CALIBRATORS (December 23, 2005)
  • K051211 — QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS (November 18, 2005)
  • K052815 — QMS AMIKACIN REAGENTS (November 1, 2005)
  • K050419 — QMS VANCOMYCIN (April 1, 2005)
  • K042307 — ARCHITECT T-UPTAKE CALIBRATORS (A-F) AND CONTROLS (LOW, HIGH) (November 3, 2004)
  • K033674 — MULTIGENT HEMOGLOBIN A1C (REAGENTS), HB A1C CALIBRATORS AND HB A1C CONTROLS (February 9, 2004)

Other clearances for product code LCR

  • 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)
  • K822197 — NEEDLE HOLDERS (August 16, 1982)

FDA data resources