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FDA 510(k)

PATHFINDER(TM) CHLAMYDIA EIA DETECT KIT/MODIFIED

K-Number: K884517 · 1988-11-30

ApplicantKallestad Diag, A Div. of Erbamont, Inc.
Decision Date1988-11-30
Product CodeLJC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PATHFINDER(TM) CHLAMYDIA EIA DETECT KIT/MODIFIED is the device name listed in this FDA 510(k) record. The listed applicant is Kallestad Diag, A Div. of Erbamont, Inc.. It received FDA 510(k) clearance on 1988-11-30 under 510(k) number K884517. 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 PATHFINDER(TM) CHLAMYDIA EIA DETECT KIT/MODIFIED?

PATHFINDER(TM) CHLAMYDIA EIA DETECT KIT/MODIFIED is a medical device that received FDA 510(k) clearance on 1988-11-30. The listed applicant is Kallestad Diag, A Div. of Erbamont, Inc.. The 510(k) number is K884517.

When did PATHFINDER(TM) CHLAMYDIA EIA DETECT KIT/MODIFIED receive FDA 510(k) clearance?

PATHFINDER(TM) CHLAMYDIA EIA DETECT KIT/MODIFIED received FDA 510(k) clearance on 1988-11-30, under 510(k) number K884517.

Who is the listed applicant for PATHFINDER(TM) CHLAMYDIA EIA DETECT KIT/MODIFIED?

The FDA 510(k) record lists Kallestad Diag, A Div. of Erbamont, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PATHFINDER(TM) CHLAMYDIA EIA DETECT KIT/MODIFIED?

The FDA product code for PATHFINDER(TM) CHLAMYDIA EIA DETECT KIT/MODIFIED is LJC.

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Other records listing Kallestad Diag, A Div. of Erbamont, 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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