510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN150035Unknown

SEEKER System

Baebies Inc., Durham NC / Direct, Unknown
FDA source (opens on fda.gov)

DEN150035 is the FDA 510(k) clearance record for SEEKER System, a class II device, cleared for Baebies, Inc. on under FDA product code PQW (Alpha-D-Galactosidase A (Gla) Newborn Screening Test System). FDA's definition for product code PQW reads: "For quantitative measurement of the activity of alpha-D-galactosidase A (GLA) from newborn dried blood spot specimens". FDA records list 3 510(k) clearances for Baebies, Inc., from to . As of , FDA records show no recalls naming DEN150035.

Clearance record

Decision date
Received
(548 days to decision)
Product code
PQW Alpha-D-Galactosidase A (Gla) Newborn Screening Test System
Regulation
21 CFR 862.1488
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Baebies, Inc. 615 Davis Dr.,, Durham NC
Third party review
No

Clearances, product code PQW

Trailing 12 months

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

FDA records show no clearances under product code PQW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PQW, 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