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FDA 510(k)

PATHFINDER(TM) CHLAMYDIA EIA BRUSH COLLECTION KIT

K-Number: K881125 · 1988-03-23

ApplicantKallestad Diag, A Div. of Erbamont, Inc.
Decision Date1988-03-23
Product CodeLIO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PATHFINDER(TM) CHLAMYDIA EIA BRUSH COLLECTION KIT 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 1988-03-23 under 510(k) number K881125. The device is classified under product code LIO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PATHFINDER(TM) CHLAMYDIA EIA BRUSH COLLECTION KIT?

PATHFINDER(TM) CHLAMYDIA EIA BRUSH COLLECTION KIT is a medical device that received FDA 510(k) clearance on 1988-03-23. The listed applicant is Kallestad Diag, A Div. of Erbamont, Inc.. The 510(k) number is K881125.

When did PATHFINDER(TM) CHLAMYDIA EIA BRUSH COLLECTION KIT receive FDA 510(k) clearance?

PATHFINDER(TM) CHLAMYDIA EIA BRUSH COLLECTION KIT received FDA 510(k) clearance on 1988-03-23, under 510(k) number K881125.

Who is the listed applicant for PATHFINDER(TM) CHLAMYDIA EIA BRUSH COLLECTION KIT?

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 BRUSH COLLECTION KIT?

The FDA product code for PATHFINDER(TM) CHLAMYDIA EIA BRUSH COLLECTION KIT is LIO.

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Other records listing Kallestad Diag, A Div. of Erbamont, Inc. as applicant

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Related Devices (Code: LIO)

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.

K222613ARX Liquid Amies Collection & Transport SystemArx Sciences, Inc.K131630PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEMPuritan Medical Products, LLCK120846TRANSPORT CULTURE MEDIUM DEVICEPuritan Medical Products, LLCK103805MEDICAL WIRE & EQUIPMENT S-TRANSWAB (OR SIGMA-TRANSWAB) LIQUID AMIES COLLECTION AND TRANSPORT DEVICEMedical Wire & Equipment Company (Bath), Ltd.K082472VIROCULT, MODEL MW950Medical Wire & Equipment Company (Bath), Ltd.K070062COPROSET SALMONELLA AND SHIGELLA, URISET PRESERVATIVE TUBES AND SWAB SET GENERAL USEDiesse Diagnostica Senese S.P.A.

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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