Cleared Traditional

K812740 - REAGENTS FOR SERODIAGNOSIS OF ASPERGILL (FDA 510(k) Clearance)

K812740 · Nolan Biological Laboratories, Inc. · Microbiology device

Oct 1981

Decision

21d

Days

Class 1

Risk

K812740 is an FDA 510(k) clearance for the REAGENTS FOR SERODIAGNOSIS OF ASPERGILL. This device is classified as a Antigen, Cf, Aspergillus Spp. (Class I - General Controls, product code JWT).

Submitted by Nolan Biological Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 20, 1981, 21 days after receiving the submission on September 29, 1981.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3040.

Submission Details

510(k) Number	K812740 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 29, 1981
Decision Date	October 20, 1981
Days to Decision	21 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—