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FDA 510(k)

PATHFINDER DIRECT ANTIGEN DETECTION SYS ROTAVIRUS

K-Number: K853554 · 1985-11-26

ApplicantKallestad Laboratories, Inc.
Decision Date1985-11-26
Product CodeLIQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PATHFINDER DIRECT ANTIGEN DETECTION SYS ROTAVIRUS 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 1985-11-26 under 510(k) number K853554. The device is classified under product code LIQ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PATHFINDER DIRECT ANTIGEN DETECTION SYS ROTAVIRUS?

PATHFINDER DIRECT ANTIGEN DETECTION SYS ROTAVIRUS is a medical device that received FDA 510(k) clearance on 1985-11-26. The listed applicant is Kallestad Laboratories, Inc.. The 510(k) number is K853554.

When did PATHFINDER DIRECT ANTIGEN DETECTION SYS ROTAVIRUS receive FDA 510(k) clearance?

PATHFINDER DIRECT ANTIGEN DETECTION SYS ROTAVIRUS received FDA 510(k) clearance on 1985-11-26, under 510(k) number K853554.

Who is the listed applicant for PATHFINDER DIRECT ANTIGEN DETECTION SYS ROTAVIRUS?

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 DIRECT ANTIGEN DETECTION SYS ROTAVIRUS?

The FDA product code for PATHFINDER DIRECT ANTIGEN DETECTION SYS ROTAVIRUS is LIQ.

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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.

K863681PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEMK862917PATHFINDER ROTAVIRUS CHEMILUMINESCENTK863682PATHFINDER(TM) SPECIMEN COLLECTION KITK862743PATHFINDER(TM) RESPIRATORY SYNCYTIAL VIRUSK862313KALLESTAD SM/RNP TEST REAGENTK862710KALLESTAD SSA/SSB ENA TEST REAGENTS

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Related Devices (Code: LIQ)

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.

K990842SAS ROTA TESTSa Scientific, Inc.K972895VIDAS ROTAVIRUS (RTV) ASSAYBiomerieux Vitek, Inc.K971585IMMUNOCARD STAT! ROTAVIRUSMeridian Diagnostics, Inc.K964424ROTAVIRUS EIATrinity Biotech, Inc.K965092VIDAS ROTAVIRUS ASSAYBiomerieux Vitek, Inc.K951208ROTA-DAN RAPID ROTAVIRUS EIA KITEldan Technologies, Ltd.

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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