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FDA 510(k)

CHLAMYDIA TISSUE CULTURE CONFIRMATION TEST (EIA)

K-Number: K862948 · 1986-10-17

ApplicantIntercare Diagnostics, Inc.
Decision Date1986-10-17
Product CodeLJC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CHLAMYDIA TISSUE CULTURE CONFIRMATION TEST (EIA) is the device name listed in this FDA 510(k) record. The listed applicant is Intercare Diagnostics, Inc.. It received FDA 510(k) clearance on 1986-10-17 under 510(k) number K862948. 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 CHLAMYDIA TISSUE CULTURE CONFIRMATION TEST (EIA)?

CHLAMYDIA TISSUE CULTURE CONFIRMATION TEST (EIA) is a medical device that received FDA 510(k) clearance on 1986-10-17. The listed applicant is Intercare Diagnostics, Inc.. The 510(k) number is K862948.

When did CHLAMYDIA TISSUE CULTURE CONFIRMATION TEST (EIA) receive FDA 510(k) clearance?

CHLAMYDIA TISSUE CULTURE CONFIRMATION TEST (EIA) received FDA 510(k) clearance on 1986-10-17, under 510(k) number K862948.

Who is the listed applicant for CHLAMYDIA TISSUE CULTURE CONFIRMATION TEST (EIA)?

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

What is the FDA product code for CHLAMYDIA TISSUE CULTURE CONFIRMATION TEST (EIA)?

The FDA product code for CHLAMYDIA TISSUE CULTURE CONFIRMATION TEST (EIA) is LJC.

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Other records listing Intercare Diagnostics, 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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