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FDA 510(k)

HUMAN IGG SUBCLASSES ELISA COMBI KIT

K-Number: K943098 · 1994-09-07

ApplicantResearch Diagnostics, Inc.
Decision Date1994-09-07
Product CodeDAS
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

HUMAN IGG SUBCLASSES ELISA COMBI KIT is the device name listed in this FDA 510(k) record. The listed applicant is Research Diagnostics, Inc.. It received FDA 510(k) clearance on 1994-09-07 under 510(k) number K943098. The device is classified under product code DAS. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HUMAN IGG SUBCLASSES ELISA COMBI KIT?

HUMAN IGG SUBCLASSES ELISA COMBI KIT is a medical device that received FDA 510(k) clearance on 1994-09-07. The listed applicant is Research Diagnostics, Inc.. The 510(k) number is K943098.

When did HUMAN IGG SUBCLASSES ELISA COMBI KIT receive FDA 510(k) clearance?

HUMAN IGG SUBCLASSES ELISA COMBI KIT received FDA 510(k) clearance on 1994-09-07, under 510(k) number K943098.

Who is the listed applicant for HUMAN IGG SUBCLASSES ELISA COMBI KIT?

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

What is the FDA product code for HUMAN IGG SUBCLASSES ELISA COMBI KIT?

The FDA product code for HUMAN IGG SUBCLASSES ELISA COMBI KIT is DAS.

Related Clinical Trials

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Other records listing Research Diagnostics, 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.

K944876HUMAN IGG SUBCLASSES NEPHELOMETRIC BNA KITK943205HUMAN IGG SUBCLASSES RID COMBI KIT (MODIFICATION)

Related Devices (Code: DAS)

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.

K982023PELICALSS HUMAN IGG SUBCLASS NEPHLOMETRIC ARRAY KITInova Diagnostics, Inc.K944876HUMAN IGG SUBCLASSES NEPHELOMETRIC BNA KITResearch Diagnostics, Inc.K943205HUMAN IGG SUBCLASSES RID COMBI KIT (MODIFICATION)Research Diagnostics, Inc.K895600HUMAN (IGG) SUBCLASS (EIA) KITThe Binding Site, Ltd.K790708ANTISERUM TO HUMAN IG G FC FRAGMENTSKent Laboratories, Inc.K790715ANTISERUM TO HUMAN FCKent Laboratories, 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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