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FDA 510(k)

FDL ELISA FOR CHLAMYDIA

K-Number: K883266 · 1988-10-25

ApplicantFairleigh Dickinson Laboratories, Inc.
Decision Date1988-10-25
Product CodeLJC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

FDL ELISA FOR CHLAMYDIA is the device name listed in this FDA 510(k) record. The listed applicant is Fairleigh Dickinson Laboratories, Inc.. It received FDA 510(k) clearance on 1988-10-25 under 510(k) number K883266. 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 FDL ELISA FOR CHLAMYDIA?

FDL ELISA FOR CHLAMYDIA is a medical device that received FDA 510(k) clearance on 1988-10-25. The listed applicant is Fairleigh Dickinson Laboratories, Inc.. The 510(k) number is K883266.

When did FDL ELISA FOR CHLAMYDIA receive FDA 510(k) clearance?

FDL ELISA FOR CHLAMYDIA received FDA 510(k) clearance on 1988-10-25, under 510(k) number K883266.

Who is the listed applicant for FDL ELISA FOR CHLAMYDIA?

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

What is the FDA product code for FDL ELISA FOR CHLAMYDIA?

The FDA product code for FDL ELISA FOR CHLAMYDIA is LJC.

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Other records listing Fairleigh Dickinson Laboratories, Inc. as applicant

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.

K896032MODIFIED ELISA FOR CHLAMYDIAK895187FDL, INC.'S TRANSPORT SYSTEMK881502BREWER GEL FOR CAMPYLOBACTERK875362BREWER GEL FOR ANAEROBESK853307DIRECT ELISA FOR HERPES SIMPLEX VIRUSK850251ROTALOK SURGICAL HAND TABLE

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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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