510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K131284Substantially Equivalent

Gsp Neonatal Biotinidase Kit

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

K131284 is the FDA 510(k) clearance record for GSP NEONATAL BIOTINIDASE KIT, a class II device, cleared for Wallac OY on under FDA product code NAK (System, Test, Biotinidase). FDA records list 24 510(k) clearances for Wallac OY, from to . As of , FDA records show no recalls naming K131284.

Clearance record

Decision date
Received
(192 days to decision)
Product code
NAK System, Test, Biotinidase
Regulation
21 CFR 862.1118
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Wallac OY 940 Winter St., Waltham MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NAK

Trailing 12 months

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

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