Home / 510(k) Clearances / K201049

510(k) K201049

FINDER G6PD by Baebies, Inc. — Product Code JBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 2022
Date Received
April 21, 2020
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 Baebies, Inc.

  • DEN150035 — SEEKER System (February 3, 2017)

Other clearances for product code JBF

  • K161364 — BinaxNOW G6PD Test (June 17, 2016)
  • 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)