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FDA 510(k)

MODIFIED IDEIA CHLAMYDIA TEST

K-Number: K880799 · 1988-12-08

ApplicantBoots-Celltech Diagnostics, Inc.
Decision Date1988-12-08
Product CodeLJC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MODIFIED IDEIA CHLAMYDIA TEST is the device name listed in this FDA 510(k) record. The listed applicant is Boots-Celltech Diagnostics, Inc.. It received FDA 510(k) clearance on 1988-12-08 under 510(k) number K880799. 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 MODIFIED IDEIA CHLAMYDIA TEST?

MODIFIED IDEIA CHLAMYDIA TEST is a medical device that received FDA 510(k) clearance on 1988-12-08. The listed applicant is Boots-Celltech Diagnostics, Inc.. The 510(k) number is K880799.

When did MODIFIED IDEIA CHLAMYDIA TEST receive FDA 510(k) clearance?

MODIFIED IDEIA CHLAMYDIA TEST received FDA 510(k) clearance on 1988-12-08, under 510(k) number K880799.

Who is the listed applicant for MODIFIED IDEIA CHLAMYDIA TEST?

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

What is the FDA product code for MODIFIED IDEIA CHLAMYDIA TEST?

The FDA product code for MODIFIED IDEIA CHLAMYDIA TEST is LJC.

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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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