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FDA 510(k)

HYCOR HY.TEC/MANUAL DS-DNA AUTO-ANTIBODY

K-Number: K962730 · 1997-03-07

ApplicantHycor Biomedical, Inc.
Decision Date1997-03-07
Product CodeLRM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

HYCOR HY.TEC/MANUAL DS-DNA AUTO-ANTIBODY is the device name listed in this FDA 510(k) record. The listed applicant is Hycor Biomedical, Inc.. It received FDA 510(k) clearance on 1997-03-07 under 510(k) number K962730. The device is classified under product code LRM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYCOR HY.TEC/MANUAL DS-DNA AUTO-ANTIBODY?

HYCOR HY.TEC/MANUAL DS-DNA AUTO-ANTIBODY is a medical device that received FDA 510(k) clearance on 1997-03-07. The listed applicant is Hycor Biomedical, Inc.. The 510(k) number is K962730.

When did HYCOR HY.TEC/MANUAL DS-DNA AUTO-ANTIBODY receive FDA 510(k) clearance?

HYCOR HY.TEC/MANUAL DS-DNA AUTO-ANTIBODY received FDA 510(k) clearance on 1997-03-07, under 510(k) number K962730.

Who is the listed applicant for HYCOR HY.TEC/MANUAL DS-DNA AUTO-ANTIBODY?

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

What is the FDA product code for HYCOR HY.TEC/MANUAL DS-DNA AUTO-ANTIBODY?

The FDA product code for HYCOR HY.TEC/MANUAL DS-DNA AUTO-ANTIBODY is LRM.

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Other records listing Hycor Biomedical, 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.

K081217HY-TEC SPECIFIC AND TOTAL IGE EIA SYSTEMK080322HY*TEC EXTENDED SPECIFIC IGE EIA, MCS ASSAY USING TECAN FREEDOM EVO RSP 200K022944AUTOSTAT II ANTI-B-2 GLYCOPROTEIN-I IGM ELISAK022945AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGG ELISAK965094HYCOR ALLERGEN DISCK962719HYCOR HY.TEC/MANUAL SS-A AUTO-ANTIBODY

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Related Devices (Code: LRM)

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.

K101319IMMULISA DSDNA ANTIBODY ELISAImmco Diagnostics, Inc.K083381EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG)Euroimmun Us, Inc.K062183FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KITThe Binding Site, Ltd.K040811VARELISA SSDNA ANTIBODIES, MODEL 14896Pharmacia Deutschland GmbHK001900ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TESTHelix Diagnostics, Inc.K000477MDI DS-DNA TESTMicro Detect, 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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