Cleared Special

K982210 - MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIA
(FDA 510(k) Clearance)

K982210 · Dade Behring, Inc. · Microbiology device

Jul 1998

Decision

16d

Days

Class 1

Risk

K982210 is an FDA 510(k) clearance for the MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIA. This device is classified as a Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) (Class I - General Controls, product code LJC).

Submitted by Dade Behring, Inc. (San Jose, US). The FDA issued a Cleared decision on July 9, 1998, 16 days after receiving the submission on June 23, 1998.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3120.

Submission Details

510(k) Number	K982210 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 23, 1998
Decision Date	July 09, 1998
Days to Decision	16 days
Submission Type	Special
Review Panel	Microbiology (MI)
Summary	Summary PDF