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FDA 510(k)

PATHFINDER(TM) DIRECT DETECTION SYS C. TRACHOMATIS

K-Number: K880031 · 1988-03-17

ApplicantKallestad Diag, A Div. of Erbamont, Inc.
Decision Date1988-03-17
Product CodeLJP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PATHFINDER(TM) DIRECT DETECTION SYS C. TRACHOMATIS 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 1988-03-17 under 510(k) number K880031. 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 DETECTION SYS C. TRACHOMATIS?

PATHFINDER(TM) DIRECT DETECTION SYS C. TRACHOMATIS is a medical device that received FDA 510(k) clearance on 1988-03-17. The listed applicant is Kallestad Diag, A Div. of Erbamont, Inc.. The 510(k) number is K880031.

When did PATHFINDER(TM) DIRECT DETECTION SYS C. TRACHOMATIS receive FDA 510(k) clearance?

PATHFINDER(TM) DIRECT DETECTION SYS C. TRACHOMATIS received FDA 510(k) clearance on 1988-03-17, under 510(k) number K880031.

Who is the listed applicant for PATHFINDER(TM) DIRECT DETECTION SYS C. TRACHOMATIS?

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) DIRECT DETECTION SYS C. TRACHOMATIS?

The FDA product code for PATHFINDER(TM) DIRECT DETECTION SYS C. TRACHOMATIS is LJP.

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

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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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