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FDA 510(k)

CHLAMYDIA IGG ELISA TEST SYSTEM

K-Number: K962558 · 1997-02-24

ApplicantArmkel, LLC
Decision Date1997-02-24
Product CodeLJC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CHLAMYDIA IGG ELISA TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Armkel, LLC. It received FDA 510(k) clearance on 1997-02-24 under 510(k) number K962558. 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 IGG ELISA TEST SYSTEM?

CHLAMYDIA IGG ELISA TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1997-02-24. The listed applicant is Armkel, LLC. The 510(k) number is K962558.

When did CHLAMYDIA IGG ELISA TEST SYSTEM receive FDA 510(k) clearance?

CHLAMYDIA IGG ELISA TEST SYSTEM received FDA 510(k) clearance on 1997-02-24, under 510(k) number K962558.

Who is the listed applicant for CHLAMYDIA IGG ELISA TEST SYSTEM?

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

What is the FDA product code for CHLAMYDIA IGG ELISA TEST SYSTEM?

The FDA product code for CHLAMYDIA IGG ELISA TEST SYSTEM is LJC.

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Other records listing Armkel, LLC 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.

K040866FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TESTK030258FIRST RESPONSE PREGNANCY TESTK023405TROJAN MINT TINGLE BRAND LATEX CONDOMSK013433TROJAN PASSION BERRY GELK013614TROJAN CRYSTAL CLEAR LIQUIDK001212TROJAN EXTRA LARGE LATEX CONDOM

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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.K960850ACCESS CHLAMYDIA ASSAYBio-Rad Laboratories, Inc.K955627VIDAS CHLAMYDIA BLOCKING ASSAYBiomerieux Vitek, 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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