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510(k) K050709

RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-9360, FR-9367 by Wallac OY — Product Code GKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 2006
Date Received
March 18, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Abnormal Hemoglobin Quantitation
Device Class
Class II
Regulation Number
864.7415
Review Panel
HE
Submission Type

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  • K081922 — AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT (April 16, 2009)
  • K071649 — NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND (August 7, 2008)
  • K070889 — AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112 (April 14, 2008)
  • K050960 — MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT (July 11, 2005)
  • K042425 — AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT (September 30, 2004)
  • K042424 — DELFIA NEONATAL 17A-OH-PROGESTERONE KIT (September 30, 2004)
  • K003664 — DELFIA NEONATAL IRT KIT, MODEL A005-110 (February 14, 2001)

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