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FDA 510(k)

RADIAS AUTOMATED IMMUNOASSAY SYSTEM

K-Number: K930898 · 1993-04-21

ApplicantBio-Rad
Decision Date1993-04-21
Product CodeJJI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RADIAS AUTOMATED IMMUNOASSAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1993-04-21 under 510(k) number K930898. The device is classified under product code JJI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADIAS AUTOMATED IMMUNOASSAY SYSTEM?

RADIAS AUTOMATED IMMUNOASSAY SYSTEM is a medical device that received FDA 510(k) clearance on 1993-04-21. The listed applicant is Bio-Rad. The 510(k) number is K930898.

When did RADIAS AUTOMATED IMMUNOASSAY SYSTEM receive FDA 510(k) clearance?

RADIAS AUTOMATED IMMUNOASSAY SYSTEM received FDA 510(k) clearance on 1993-04-21, under 510(k) number K930898.

Who is the listed applicant for RADIAS AUTOMATED IMMUNOASSAY SYSTEM?

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

What is the FDA product code for RADIAS AUTOMATED IMMUNOASSAY SYSTEM?

The FDA product code for RADIAS AUTOMATED IMMUNOASSAY SYSTEM is JJI.

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Other records listing Bio-Rad 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.

K171061MRSASelect IIK122187VRESELECT CULTURE MEDIUMK103684VRESELECT CULTURE MEDIUMK093678PLATELIA ASPERGILLUS EIA MODEL 62793K100589MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENSK081362PLATELIA LYME IGM

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Related Devices (Code: JJI)

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.

K972024CODA AUTOMATED EIA ANALYZERBio-RadK944731ABBOTT IMX 2 ANALYZERAbbott LaboratoriesK931970ABBOTT IMX2 ANALYERAbbott LaboratoriesK790073ANALYZER, IMPACT 100Gilford Instrument Laboratories, Inc.K780972QUICKRATE REACTION RATE ANALYZEROlympus Corp.K771591MINISTAT-S CHEMISTRY ANALYZERBiokinetix Corp.

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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