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510(k) K933934

GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY SCREENING TEST KIT NO. 202-A by Sigma Diagnostics, Inc. — Product Code JBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 1995
Date Received
August 11, 1993
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

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Other clearances for product code JBF

  • K201049 — FINDER G6PD (September 14, 2022)
  • K161364 — BinaxNOW G6PD Test (June 17, 2016)
  • K080003 — BINAXNOW G6PD TEST (October 23, 2008)
  • K024006 — G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE (March 31, 2003)