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FDA 510(k)

PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEM

K-Number: K863681 · 1986-12-03

ApplicantKallestad Laboratories, Inc.
Decision Date1986-12-03
Product CodeLJP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Kallestad Laboratories, Inc.. It received FDA 510(k) clearance on 1986-12-03 under 510(k) number K863681. The device is classified under product code LJP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEM?

PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEM is a medical device that received FDA 510(k) clearance on 1986-12-03. The listed applicant is Kallestad Laboratories, Inc.. The 510(k) number is K863681.

When did PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEM receive FDA 510(k) clearance?

PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEM received FDA 510(k) clearance on 1986-12-03, under 510(k) number K863681.

Who is the listed applicant for PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEM?

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

What is the FDA product code for PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEM?

The FDA product code for PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEM is LJP.

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Other records listing Kallestad 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.

K862917PATHFINDER ROTAVIRUS CHEMILUMINESCENTK863682PATHFINDER(TM) SPECIMEN COLLECTION KITK862743PATHFINDER(TM) RESPIRATORY SYNCYTIAL VIRUSK862313KALLESTAD SM/RNP TEST REAGENTK862710KALLESTAD SSA/SSB ENA TEST REAGENTSK855014QUANTIMETRIC PLUS CALIBRATOR/CONTROL SET A

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Related Devices (Code: LJP)

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.

K063675DIAGNOSTIC HYBRIDS' D3 DFA CHLAMYDIAE CULTURE CONFIRMATION KITDiagnostic Hybrids, Inc.K941714CHLAMYDIA TRACHOMATIS ANTIGEN TESTNeogenexK901243CHLAMYDIA-CEL IMMUNOFLUORENSCENCE (IF) TESTCel Labs Pty, Ltd.K900870PATHODX CHLAMYDIA TRACHOMATIS DIRECT SPECIMEN TESTDiagnostic Products Corp.K895839PATHODX CHLAMYDIA CULTURE CONFIRMATION PKCC1Diagnostic Products Corp.K883352FLUORESCEIN CONJUGATED ANTI-CHLAMYDIA MONO ANTIWhittaker Bioproducts, 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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