Cleared Traditional

K873670 - SNAP CAMPYLOBACTOR DIAGNOSTIC KIT
(FDA 510(k) Clearance)

K873670 · Molecular Biosystems, Inc. · Microbiology device

Jun 1988

Decision

271d

Days

Class 1

Risk

K873670 is an FDA 510(k) clearance for the SNAP CAMPYLOBACTOR DIAGNOSTIC KIT. This device is classified as a Dna-reagents, Campylobacter Spp. (Class I - General Controls, product code LQO).

Submitted by Molecular Biosystems, Inc. (San Diego, US). The FDA issued a Cleared decision on June 8, 1988, 271 days after receiving the submission on September 11, 1987.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3110.

Submission Details

510(k) Number	K873670 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 11, 1987
Decision Date	June 08, 1988
Days to Decision	271 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—