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FDA 510(k)

VISIBLE-CHLAMYDIA(TM) TEST SYSTEM

K-Number: K862638 · 1986-08-26

ApplicantIsolab, Inc.
Decision Date1986-08-26
Product CodeLJC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VISIBLE-CHLAMYDIA(TM) TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Isolab, Inc.. It received FDA 510(k) clearance on 1986-08-26 under 510(k) number K862638. 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 VISIBLE-CHLAMYDIA(TM) TEST SYSTEM?

VISIBLE-CHLAMYDIA(TM) TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1986-08-26. The listed applicant is Isolab, Inc.. The 510(k) number is K862638.

When did VISIBLE-CHLAMYDIA(TM) TEST SYSTEM receive FDA 510(k) clearance?

VISIBLE-CHLAMYDIA(TM) TEST SYSTEM received FDA 510(k) clearance on 1986-08-26, under 510(k) number K862638.

Who is the listed applicant for VISIBLE-CHLAMYDIA(TM) TEST SYSTEM?

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

What is the FDA product code for VISIBLE-CHLAMYDIA(TM) TEST SYSTEM?

The FDA product code for VISIBLE-CHLAMYDIA(TM) TEST SYSTEM is LJC.

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Other records listing Isolab, Inc. as applicant

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Related Devices (Code: LJC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K032330CT OIAThermo Biostar, Inc.K033865IDEIA PCE CHLAMYDIADakocytomation, Ltd.K033079CHLAMYDIA IGG ELISA TEST SYSTEMTrinity Biotech USAK982210MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIADade Behring, Inc.K962558CHLAMYDIA IGG ELISA TEST SYSTEMArmkel, LLCK960850ACCESS CHLAMYDIA ASSAYBio-Rad Laboratories, Inc.

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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