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FDA 510(k)

PAR-ONE

K-Number: K981391 · 1998-07-14

ApplicantRemel, Inc.
Decision Date1998-07-14
Product CodeLIO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PAR-ONE is the device name listed in this FDA 510(k) record. The listed applicant is Remel, Inc.. It received FDA 510(k) clearance on 1998-07-14 under 510(k) number K981391. 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 PAR-ONE?

PAR-ONE is a medical device that received FDA 510(k) clearance on 1998-07-14. The listed applicant is Remel, Inc.. The 510(k) number is K981391.

When did PAR-ONE receive FDA 510(k) clearance?

PAR-ONE received FDA 510(k) clearance on 1998-07-14, under 510(k) number K981391.

Who is the listed applicant for PAR-ONE?

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

What is the FDA product code for PAR-ONE?

The FDA product code for PAR-ONE is LIO.

Other records listing Remel, 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.

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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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