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510(k) K924186

LPIA-FERRITIN ASSAY by Seradyn, Inc. — Product Code DEF

K924186 is an FDA 510(k) premarket notification submitted by Seradyn, Inc. for the device "LPIA-FERRITIN ASSAY". The FDA issued a decision of Substantially Equivalent on December 23, 1992. The device falls under product code DEF (Alpha-2-Hs-Glycoprotein, Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5425. Seradyn, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 1992
Date Received
August 20, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alpha-2-Hs-Glycoprotein, Antigen, Antiserum, Control
Device Class
Class I
Regulation Number
866.5425
Review Panel
IM
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)
  • 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)

FDA data resources