510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K071649Substantially Equivalent

Neonatal Total Galactose Kit; Neontal Total Galactose Kit, Models 3029-0010 and 3029-110B

Wallac Oy, Waltham MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K071649 is the FDA 510(k) clearance record for NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110B, a class I device, cleared for Wallac OY on under FDA product code JIA (Enzymatic Methods, Galactose). FDA records list 24 510(k) clearances for Wallac OY, from to . As of , FDA records show 3 recalls naming K071649.

Clearance record

Decision date
Received
(416 days to decision)
Product code
JIA Enzymatic Methods, Galactose
Regulation
21 CFR 862.1310
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Wallac OY 940 Winter St., Waltham MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JIA

Trailing 12 months

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

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