Device Atlas

Finder G6PD

Q: When was Finder G6PD cleared by the FDA?

Finder G6PD (K201049) received a 510(k) decision of Substantially Equivalent on September 14, 2022, 876 days after the submission was received.

Q: What is the product code of K201049?

The FDA product code is JBF – Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening, a Class II (moderate risk) device regulated under 21 CFR 864.7360.

FDA 510(k) K201049 · Baebies, Inc.

Substantially Equivalent

510(k) numberK201049

Submission

Device name: Finder G6PD
Applicant: Baebies, Inc.
Morrisville, NC, US
Received: April 21, 2020
Decision date: September 14, 2022
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: JBF – Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening
Device class: Class II (moderate risk)
Regulation: 21 CFR 864.7360
Specialty: Hematology

Other 510(k)s with product code JBF

510(k)	Device	Applicant	Decision
K161364	BinaxNOW G6PD TestJBF · Special	Alere Scarborough, Inc.	06/17/2016SE
K080003	Binaxnow G6PD TestJBF · Traditional	Binax, Inc.	10/23/2008SE
K024006	G6PDH, GLUCOSE-6-PHOSHATE DehydrogenaseJBF · Traditional	Pointe Scientific, Inc.,	03/31/2003SE
K933934	GLUCOSE-6-PHOSPHATE Dehydrogenase Deficiency Screening Test Kit No. 202-AJBF · Traditional	Sigma Diagnostics, Inc.	06/29/1995SE

More from Sigma Diagnostics, Inc.

510(k)	Device	Decision
K261837	FINDER Flu A&B/SARS-CoV-2 TestQOF · Traditional	09/11/2026SE
K252269	FINDER Flu A&B/SARS-CoV-2 TestQOF · Dual Track	03/30/2026SE

Questions and answers

When was Finder G6PD cleared by the FDA?

Finder G6PD (K201049) received a 510(k) decision of Substantially Equivalent on September 14, 2022, 876 days after the submission was received.

What is the product code of K201049?

The FDA product code is JBF – Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening, a Class II (moderate risk) device regulated under 21 CFR 864.7360.