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510(k) K934388

QMS PHENOBARBITAL by Seradyn, Inc. — Product Code LFN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 1994
Date Received
September 9, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nephelometric Inhibition Immunoassay, Phenobarbital
Device Class
Class II
Regulation Number
862.3660
Review Panel
TX
Submission Type

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  • K062204 — ARCHITECT CORTISOL ASSAY (September 22, 2006)
  • K060998 — QMS TOBRAMYCIN (July 21, 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)

Other clearances for product code LFN

  • K864612 — DART PHENOBARBITAL ASSAY SYSTEM (January 13, 1987)
  • K860303 — DUPONT PHENOBARBITAL CALIBRATOR (February 28, 1986)
  • K860304 — DUPONT PHENOBARBITAL ASSAY (February 28, 1986)
  • K821543 — IPA FOR DETECTION OF PHENOBARBITAL (June 3, 1982)