Cleared Traditional

ACCESS CHLAMYDIA ASSAY

K960850 · Bio-Rad Laboratories, Inc. · Microbiology
Feb 1997
Decision
340d
Days
Class 1
Risk

About This 510(k) Submission

K960850 is an FDA 510(k) clearance for the ACCESS CHLAMYDIA ASSAY, a Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) (Class I — General Controls, product code LJC), submitted by Bio-Rad Laboratories, Inc. (Chaska, US). The FDA issued a Cleared decision on February 4, 1997, 340 days after receiving the submission on March 1, 1996. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3120.

Submission Details

510(k) Number K960850 FDA.gov
FDA Decision Cleared SESE
Date Received March 01, 1996
Decision Date February 04, 1997
Days to Decision 340 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LJC — Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group)
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3120

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