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FDA 510(k)

CODA AUTOMATED EIA ANALYZER

K-Number: K972024 · 1997-07-30

ApplicantBio-Rad
Decision Date1997-07-30
Product CodeJJI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CODA AUTOMATED EIA ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1997-07-30 under 510(k) number K972024. 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 CODA AUTOMATED EIA ANALYZER?

CODA AUTOMATED EIA ANALYZER is a medical device that received FDA 510(k) clearance on 1997-07-30. The listed applicant is Bio-Rad. The 510(k) number is K972024.

When did CODA AUTOMATED EIA ANALYZER receive FDA 510(k) clearance?

CODA AUTOMATED EIA ANALYZER received FDA 510(k) clearance on 1997-07-30, under 510(k) number K972024.

Who is the listed applicant for CODA AUTOMATED EIA ANALYZER?

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 CODA AUTOMATED EIA ANALYZER?

The FDA product code for CODA AUTOMATED EIA ANALYZER 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.

K944731ABBOTT IMX 2 ANALYZERAbbott LaboratoriesK931970ABBOTT IMX2 ANALYERAbbott LaboratoriesK930898RADIAS AUTOMATED IMMUNOASSAY SYSTEMBio-RadK790073ANALYZER, 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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