Cleared Traditional

STOOL-COLLECTION/PRESERVATION KIT

K822870 · American Scientific Products · Microbiology
Nov 1982
Decision
35d
Days
Class 1
Risk

About This 510(k) Submission

K822870 is an FDA 510(k) clearance for the STOOL-COLLECTION/PRESERVATION KIT, a Container, Specimen Mailer And Storage, Sterile (Class I — General Controls, product code KDT), submitted by American Scientific Products (Mchenry, US). The FDA issued a Cleared decision on November 1, 1982, 35 days after receiving the submission on September 27, 1982. This device falls under the Microbiology review panel. Regulated under 21 CFR 864.3250.

Submission Details

510(k) Number K822870 FDA.gov
FDA Decision Cleared SESE
Date Received September 27, 1982
Decision Date November 01, 1982
Days to Decision 35 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code KDT — Container, Specimen Mailer And Storage, Sterile
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.3250

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