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FDA 510(k)

PLATELIA ASPERGILLUS EIA, MODELS 62793 AND 62794

K-Number: K023857 · 2003-05-16

ApplicantBio-Rad
Decision Date2003-05-16
Product CodeNOM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PLATELIA ASPERGILLUS EIA, MODELS 62793 AND 62794 is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 2003-05-16 under 510(k) number K023857. The device is classified under product code NOM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLATELIA ASPERGILLUS EIA, MODELS 62793 AND 62794?

PLATELIA ASPERGILLUS EIA, MODELS 62793 AND 62794 is a medical device that received FDA 510(k) clearance on 2003-05-16. The listed applicant is Bio-Rad. The 510(k) number is K023857.

When did PLATELIA ASPERGILLUS EIA, MODELS 62793 AND 62794 receive FDA 510(k) clearance?

PLATELIA ASPERGILLUS EIA, MODELS 62793 AND 62794 received FDA 510(k) clearance on 2003-05-16, under 510(k) number K023857.

Who is the listed applicant for PLATELIA ASPERGILLUS EIA, MODELS 62793 AND 62794?

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 PLATELIA ASPERGILLUS EIA, MODELS 62793 AND 62794?

The FDA product code for PLATELIA ASPERGILLUS EIA, MODELS 62793 AND 62794 is NOM.

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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: NOM)

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.

K243496MycoMEIA Aspergillus AssayPearl Diagnostics, Inc.K093678PLATELIA ASPERGILLUS EIA MODEL 62793Bio-RadK060641PLATELIA ASPERGILLUS EIA, MODEL 62793Bio-Rad

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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