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510(k) K080003

BINAXNOW G6PD TEST by Binax, Inc. — Product Code JBF

K080003 is an FDA 510(k) premarket notification submitted by Binax, Inc. for the device "BINAXNOW G6PD TEST". The FDA issued a decision of Substantially Equivalent on October 23, 2008. The device falls under product code JBF (Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening), a Class II device regulated under 21 CFR 864.7360. Binax, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 2008
Date Received
January 2, 2008
Clearance Type
Traditional
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

Other clearances by Binax, Inc.

  • K090301 — BINAXNOW PBP2A TEST, MODEL 890-000 (April 14, 2010)
  • K091766 — CLEARVIEW EXACT PBP2A TEST, MODEL 891-000 (February 24, 2010)
  • K090964 — BINAXNOX STAPHYLOCOCCUS AUREUS TEST (December 16, 2009)
  • K091489 — CLEARVIEW ADVANCED STREP A , MODEL 737-430 (September 4, 2009)
  • K083744 — BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010 (September 1, 2009)
  • K092223 — MODIFICATION TO: BINAXNOW INFLUENZA A & B TEST (August 12, 2009)
  • K062109 — BINAXNOW INFLUENZA A & B TEST (November 9, 2006)
  • K053126 — BINAXNOW INFLUENZA A & B TEST (November 30, 2005)
  • K041049 — BINAXNOW INFLUENZA A & B TEST (August 10, 2004)
  • K032166 — BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PA (October 21, 2003)

Other clearances for product code JBF

  • K201049 — FINDER G6PD (September 14, 2022)
  • K161364 — BinaxNOW G6PD Test (June 17, 2016)
  • K024006 — G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE (March 31, 2003)
  • K933934 — GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY SCREENING TEST KIT NO. 202-A (June 29, 1995)

FDA data resources