510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K201049Substantially Equivalent

Finder G6pd

Baebies Inc., Morrisville NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K201049 is the FDA 510(k) clearance record for FINDER G6PD, a class II device, cleared for Baebies, Inc. on under FDA product code JBF (Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening). FDA records list 3 510(k) clearances for Baebies, Inc., from to . As of , FDA records show no recalls naming K201049.

Clearance record

Decision date
Received
(876 days to decision)
Product code
JBF Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening
Regulation
21 CFR 864.7360
Device class
Class II
Review panel
Hematology
Applicant
Baebies, Inc. 615 Davis Dr., Suite 800, Morrisville NC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JBF

Trailing 12 months

FDA records hold no clearances under product code JBF in the trailing twelve months.

FDA records show no clearances under product code JBF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JBF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260