510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN180056Unknown

GSP Neonatal Creatine Kinase - MM kit

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

DEN180056 is the FDA 510(k) clearance record for GSP Neonatal Creatine Kinase - MM kit, a class II device, cleared for Perkinelmer, Inc. on under FDA product code QJE (Muscular Dystrophy Newborn Screening Test). FDA's definition for product code QJE reads: "A muscular dystrophy newborn screening test is intended to measure creatine kinase levels obtained from dried blood spot specimens on filter paper from newborns as an aid in screening newborns for muscular dystrophy". FDA records list 81 510(k) clearances for Revvity Health Sciences, Inc., from to . As of , FDA records show no recalls naming DEN180056.

Clearance record

Decision date
Received
(427 days to decision)
Product code
QJE Muscular Dystrophy Newborn Screening Test
Regulation
21 CFR 862.1506
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Perkinelmer, Inc. 940 Winter St., Waltham MA
Third party review
No

Clearances, product code QJE

Trailing 12 months

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

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