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
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K932661Substantially Equivalent

Whatman Body Fluid Collection Paper:whatman Bfc180

Whatman Specialty Products, Inc., Fairfield NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K932661 is the FDA 510(k) clearance record for WHATMAN BODY FLUID COLLECTION PAPER:WHATMAN BFC180, a class II device, cleared for Whatman Specialty Products, 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 one 510(k) clearance for Whatman Specialty Products, Inc. As of , FDA records show 3 recalls naming K932661.

Clearance record

Decision date
Received
(1,050 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
Whatman Specialty Products, Inc. 6 Just Rd., Fairfield NJ
510(k) summary
Statement
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