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510(k) K161364

BinaxNOW G6PD Test by Alere Scarborough, Inc. — Product Code JBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 2016
Date Received
May 17, 2016
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening
Device Class
Class II
Regulation Number
864.7360
Review Panel
HE
Submission Type

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  • K161375 — Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit (August 18, 2016)

Other clearances for product code JBF

  • K201049 — FINDER G6PD (September 14, 2022)
  • K080003 — BINAXNOW G6PD TEST (October 23, 2008)
  • K024006 — G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE (March 31, 2003)
  • K933934 — GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY SCREENING TEST KIT NO. 202-A (June 29, 1995)