FDA 510(k)

CHLAMYDIA-CEL IMMUNOFLUORENSCENCE (IF) TEST

K-Number: K901243 · 1990-05-21

Decision Date1990-05-21

Product CodeLJP

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

CHLAMYDIA-CEL IMMUNOFLUORENSCENCE (IF) TEST is the device name listed in this FDA 510(k) record. The listed applicant is Cel Labs Pty, Ltd.. It received FDA 510(k) clearance on 1990-05-21 under 510(k) number K901243. The device is classified under product code LJP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHLAMYDIA-CEL IMMUNOFLUORENSCENCE (IF) TEST?

CHLAMYDIA-CEL IMMUNOFLUORENSCENCE (IF) TEST is a medical device that received FDA 510(k) clearance on 1990-05-21. The listed applicant is Cel Labs Pty, Ltd.. The 510(k) number is K901243.

When did CHLAMYDIA-CEL IMMUNOFLUORENSCENCE (IF) TEST receive FDA 510(k) clearance?

CHLAMYDIA-CEL IMMUNOFLUORENSCENCE (IF) TEST received FDA 510(k) clearance on 1990-05-21, under 510(k) number K901243.

Who is the listed applicant for CHLAMYDIA-CEL IMMUNOFLUORENSCENCE (IF) TEST?

The FDA 510(k) record lists Cel Labs Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHLAMYDIA-CEL IMMUNOFLUORENSCENCE (IF) TEST?

The FDA product code for CHLAMYDIA-CEL IMMUNOFLUORENSCENCE (IF) TEST is LJP.

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Official Source

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