Cleared Traditional

K800947 - MIDSTREAM COLLECTION KIT (FDA 510(k) Clearance)

K800947 · Sage Products, Inc. · General Hospital

May 1980

Decision

38d

Days

Class 1

Risk

K800947 is an FDA 510(k) clearance for the MIDSTREAM COLLECTION KIT. This device is classified as a Container, Specimen, Sterile (Class I - General Controls, product code FMH).

Submitted by Sage Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 30, 1980, 38 days after receiving the submission on April 22, 1980.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 864.3250.

Submission Details

510(k) Number	K800947 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 22, 1980
Decision Date	May 30, 1980
Days to Decision	38 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	—