Home / 510(k) Clearances / K924813

510(k) K924813

VARIANT SICKLE CELL SHORT PROGRAM by Bio-Rad — Product Code GKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 1993
Date Received
September 25, 1992
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

Other clearances by Bio-Rad

  • K171061 — MRSASelect II (December 28, 2017)
  • K122187 — VRESELECT CULTURE MEDIUM (November 6, 2012)
  • K103684 — VRESELECT CULTURE MEDIUM (October 21, 2011)
  • K093678 — PLATELIA ASPERGILLUS EIA MODEL 62793 (January 13, 2011)
  • K100589 — MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS (October 29, 2010)
  • K081362 — PLATELIA LYME IGM (June 26, 2008)
  • K081212 — MRSASELECT - EXTENDED INCUBATION (June 13, 2008)
  • K080012 — PLATELIA LYME IGG ASSAY (May 8, 2008)
  • K070361 — MRSASELECT (September 13, 2007)
  • K060641 — PLATELIA ASPERGILLUS EIA, MODEL 62793 (June 2, 2006)

Other clearances for product code GKA

  • K232027 — CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument (April 4, 2024)
  • K222635 — Premier Resolution System (August 4, 2023)
  • K192931 — V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control (April 19, 2022)
  • K180762 — CAPI 3 HEMOGLOBIN(E) (December 14, 2018)
  • K171664 — Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview So (September 13, 2017)
  • 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)