Cleared Traditional

K812367 - GOOSE BLOOD IN ALSEVER'S, CITRATED (ACD)
(FDA 510(k) Clearance)

K812367 · Dutchland Laboratories, Inc. · Immunology

Sep 1981

Decision

20d

Days

Class 1

Risk

K812367 is an FDA 510(k) clearance for the GOOSE BLOOD IN ALSEVER'S, CITRATED (ACD), a Staphylococcus Aureus Somatic Antigens (Class I — General Controls, product code LHT), submitted by Dutchland Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 9, 1981, 20 days after receiving the submission on August 20, 1981. This device falls under the Immunology review panel. Regulated under 21 CFR 866.3700.

Submission Details

510(k) Number	K812367 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 20, 1981
Decision Date	September 09, 1981
Days to Decision	20 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	—