510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN200044Unknown

Eonis SCID-SMA Kit

Revvity Health Sciences, Inc., Waltham MA / Direct, Unknown
FDA source (opens on fda.gov)

DEN200044 is the FDA 510(k) clearance record for Eonis SCID-SMA Kit, a class II device, cleared for Perkinelmer, Inc. on under FDA product code QUE (Spinal Muscular Atrophy Newborn Screening Test System). FDA's definition for product code QUE reads: "A Spinal Muscular Atrophy (SMA) newborn screening test system is a prescription device intended to detect homozygous deletion of exon 7 or other similar mutations in the SMN1 (Survival Motor Neuron 1) gene of DNA obtained from dried blood...". FDA records list 81 510(k) clearances for Revvity Health Sciences, Inc., from to . As of , FDA records show no recalls naming DEN200044.

Clearance record

Decision date
Received
(854 days to decision)
Product code
QUE Spinal Muscular Atrophy Newborn Screening Test System
Regulation
21 CFR 866.5980
Device class
Class II
Review panel
Immunology
Applicant
Perkinelmer, Inc. 940 Winter St., Waltham MA
Third party review
No

Clearances, product code QUE

Trailing 12 months

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

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