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FDA 510(k)

HUMAN IGG SUBCLASSES NEPHELOMETRIC BNA KIT

K-Number: K944876 · 1994-12-15

ApplicantResearch Diagnostics, Inc.
Decision Date1994-12-15
Product CodeDAS
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

HUMAN IGG SUBCLASSES NEPHELOMETRIC BNA 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 1994-12-15 under 510(k) number K944876. 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 NEPHELOMETRIC BNA KIT?

HUMAN IGG SUBCLASSES NEPHELOMETRIC BNA KIT is a medical device that received FDA 510(k) clearance on 1994-12-15. The listed applicant is Research Diagnostics, Inc.. The 510(k) number is K944876.

When did HUMAN IGG SUBCLASSES NEPHELOMETRIC BNA KIT receive FDA 510(k) clearance?

HUMAN IGG SUBCLASSES NEPHELOMETRIC BNA KIT received FDA 510(k) clearance on 1994-12-15, under 510(k) number K944876.

Who is the listed applicant for HUMAN IGG SUBCLASSES NEPHELOMETRIC BNA 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 NEPHELOMETRIC BNA KIT?

The FDA product code for HUMAN IGG SUBCLASSES NEPHELOMETRIC BNA KIT is DAS.

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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.

K943098HUMAN IGG SUBCLASSES ELISA COMBI 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.K943098HUMAN IGG SUBCLASSES ELISA COMBI 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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