FDA 510(k)

FINDER G6PD

K-Number: K201049 · 2022-09-14

Decision Date2022-09-14

Product CodeJBF

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

FINDER G6PD is the device name listed in this FDA 510(k) record. The listed applicant is Baebies, Inc.. It received FDA 510(k) clearance on 2022-09-14 under 510(k) number K201049. The device is classified under product code JBF. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FINDER G6PD?

FINDER G6PD is a medical device that received FDA 510(k) clearance on 2022-09-14. The listed applicant is Baebies, Inc.. The 510(k) number is K201049.

When did FINDER G6PD receive FDA 510(k) clearance?

FINDER G6PD received FDA 510(k) clearance on 2022-09-14, under 510(k) number K201049.

Who is the listed applicant for FINDER G6PD?

The FDA 510(k) record lists Baebies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FINDER G6PD?

The FDA product code for FINDER G6PD is JBF.

Other records listing Baebies, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252269FINDER Flu A&B/SARS-CoV-2 Test

Related Devices (Code: JBF)

K161364BinaxNOW G6PD TestAlere Scarborough, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.