510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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K100101Substantially Equivalent

Gsp Neonatalgalt Kit, Model 3303-001U

Revvity Health Sciences, Inc., Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K100101 is the FDA 510(k) clearance record for GSP NEONATALGALT KIT, MODEL 3303-001U, a class II device, cleared for Perkinelmer, Inc. on under FDA product code KQP (Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase). FDA records list 81 510(k) clearances for Revvity Health Sciences, Inc., from to . As of , FDA records show one recall naming K100101.

Clearance record

Decision date
Received
(149 days to decision)
Product code
KQP Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase
Regulation
21 CFR 862.1315
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Perkinelmer, Inc. 8275 Carloway Rd., Indianapolis IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KQP

Trailing 12 months

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

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