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FDA 510(k)

ROMCHECK SPECIMEN COLLECTION KIT

K-Number: K900225 · 1990-02-02

ApplicantAdeza Biomedical
Decision Date1990-02-02
Product CodeLIO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ROMCHECK SPECIMEN COLLECTION KIT is the device name listed in this FDA 510(k) record. The listed applicant is Adeza Biomedical. It received FDA 510(k) clearance on 1990-02-02 under 510(k) number K900225. 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 ROMCHECK SPECIMEN COLLECTION KIT?

ROMCHECK SPECIMEN COLLECTION KIT is a medical device that received FDA 510(k) clearance on 1990-02-02. The listed applicant is Adeza Biomedical. The 510(k) number is K900225.

When did ROMCHECK SPECIMEN COLLECTION KIT receive FDA 510(k) clearance?

ROMCHECK SPECIMEN COLLECTION KIT received FDA 510(k) clearance on 1990-02-02, under 510(k) number K900225.

Who is the listed applicant for ROMCHECK SPECIMEN COLLECTION KIT?

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

What is the FDA product code for ROMCHECK SPECIMEN COLLECTION KIT?

The FDA product code for ROMCHECK SPECIMEN COLLECTION KIT is LIO.

Related Clinical Trials

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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Other records listing Adeza Biomedical 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.

K911047OBA(TM) SERUM HCG ASSAYK911045OBA(TM) READER

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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