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FDA 510(k)

ROUND 1

K-Number: K873086 · 1987-08-24

ApplicantBioclinical Systems, Inc.
Decision Date1987-08-24
Product CodeJXA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ROUND 1 is the device name listed in this FDA 510(k) record. The listed applicant is Bioclinical Systems, Inc.. It received FDA 510(k) clearance on 1987-08-24 under 510(k) number K873086. The device is classified under product code JXA. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROUND 1?

ROUND 1 is a medical device that received FDA 510(k) clearance on 1987-08-24. The listed applicant is Bioclinical Systems, Inc.. The 510(k) number is K873086.

When did ROUND 1 receive FDA 510(k) clearance?

ROUND 1 received FDA 510(k) clearance on 1987-08-24, under 510(k) number K873086.

Who is the listed applicant for ROUND 1?

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

What is the FDA product code for ROUND 1?

The FDA product code for ROUND 1 is JXA.

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Other records listing Bioclinical Systems, 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.

K950196CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIAK945911CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGARSK933122MICROBIOLOGICAL CULTURE MEDIA,MARTIN LEWIS AGARK933121MICROBIOLOGICAL CULTURE MEDIA,CHOCOLATE AGARK860334VISI-CHECK HLH TEST MONOCLONALK860333MICRO-ELISA HLH TEST KIT MONOCLONAL

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Related Devices (Code: JXA)

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.

K011043OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI)OsmetechK981084URISCREENDiatech Diagnostics,Inc.K972676URINE SCREENING DEVICECombact Diagnostic Systems , Ltd.K952246TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KITTri-Tech, Inc.K950257MULTIPLE (IZON DBS & URINE COLLECTION KIT)Izon Business Products, Inc.K950246MULTIPLE (IZON URINE COLLECTION KIT)Izon Business Products, 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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