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FDA 510(k)

PATHFINDER ROTAVIRUS CHEMILUMINESCENT

K-Number: K862917 · 1986-10-22

ApplicantKallestad Laboratories, Inc.
Decision Date1986-10-22
Product CodeLIQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PATHFINDER ROTAVIRUS CHEMILUMINESCENT 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 1986-10-22 under 510(k) number K862917. 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 ROTAVIRUS CHEMILUMINESCENT?

PATHFINDER ROTAVIRUS CHEMILUMINESCENT is a medical device that received FDA 510(k) clearance on 1986-10-22. The listed applicant is Kallestad Laboratories, Inc.. The 510(k) number is K862917.

When did PATHFINDER ROTAVIRUS CHEMILUMINESCENT receive FDA 510(k) clearance?

PATHFINDER ROTAVIRUS CHEMILUMINESCENT received FDA 510(k) clearance on 1986-10-22, under 510(k) number K862917.

Who is the listed applicant for PATHFINDER ROTAVIRUS CHEMILUMINESCENT?

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 ROTAVIRUS CHEMILUMINESCENT?

The FDA product code for PATHFINDER ROTAVIRUS CHEMILUMINESCENT 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 SYSTEMK863682PATHFINDER(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: 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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