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510(k) K192931

V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control by Helena Laboratories, Corp. — Product Code GKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 2022
Date Received
October 17, 2019
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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  • K024162 — SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389 (February 19, 2003)
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  • K112550 — CAPILLARYS HEMOGLOBIN, CAPILLARYS FLEX PIERCING SYSTEM (May 25, 2012)
  • K112491 — SEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 2 (May 24, 2012)
  • K091283 — CAPILLARYS NEONAT HB (PN 2006) (February 22, 2010)
  • K082227 — MINICAP HEMOGLOBIN(E) KIT, MODEL 2207, 2227 (March 26, 2009)
  • K080911 — VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING SYSTE (May 2, 2008)
  • K052291 — CAPILLARY'S HEMOGLOBIN(E) (PN 2007) (June 27, 2006)