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FDA 510(k)

MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIA

K-Number: K982210 · 1998-07-09

ApplicantDade Behring, Inc.
Decision Date1998-07-09
Product CodeLJC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIA is the device name listed in this FDA 510(k) record. The listed applicant is Dade Behring, Inc.. It received FDA 510(k) clearance on 1998-07-09 under 510(k) number K982210. The device is classified under product code LJC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIA?

MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIA is a medical device that received FDA 510(k) clearance on 1998-07-09. The listed applicant is Dade Behring, Inc.. The 510(k) number is K982210.

When did MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIA receive FDA 510(k) clearance?

MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIA received FDA 510(k) clearance on 1998-07-09, under 510(k) number K982210.

Who is the listed applicant for MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIA?

The FDA 510(k) record lists Dade Behring, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIA?

The FDA product code for MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIA is LJC.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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