510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K121864Substantially Equivalent

Perkinelmer 226 Sample Collection Devices

Revvity Health Sciences, Inc., Greenville SC / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K121864 is the FDA 510(k) clearance record for PERKINELMER 226 SAMPLE COLLECTION DEVICES, a class II device, cleared for Perkinelmer, Inc. on under FDA product code PJC (Newborn Screening Specimen Collection Paper). FDA's definition for product code PJC reads: "Newborn screening specimen collection paper is a blood collection device intended to be used as medium to collect and transport whole blood specimens from newborns to the laboratory for in vitro diagnostic analysis". FDA records list 81 510(k) clearances for Revvity Health Sciences, Inc., from to . As of , FDA records show 3 recalls naming K121864.

Clearance record

Decision date
Received
(259 days to decision)
Product code
PJC Newborn Screening Specimen Collection Paper
Regulation
21 CFR 862.1675
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Perkinelmer, Inc. 17 P&N Dr., Greenville SC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PJC

Trailing 12 months

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

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