Cleared Traditional

WHATMAN BODY FLUID COLLECTION PAPER:WHATMAN BFC180

K932661 · Whatman Specialty Products, Inc. · Chemistry
Apr 1996
Decision
1050d
Days
Class 2
Risk

About This 510(k) Submission

K932661 is an FDA 510(k) clearance for the WHATMAN BODY FLUID COLLECTION PAPER:WHATMAN BFC180, a Newborn Screening Specimen Collection Paper (Class II — Special Controls, product code PJC), submitted by Whatman Specialty Products, Inc. (Fairfield, US). The FDA issued a Cleared decision on April 17, 1996, 1050 days after receiving the submission on June 2, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1675.

Submission Details

510(k) Number K932661 FDA.gov
FDA Decision Cleared SESE
Date Received June 02, 1993
Decision Date April 17, 1996
Days to Decision 1050 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code PJC — Newborn Screening Specimen Collection Paper
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1675
Definition 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.