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FDA 510(k)

HY-TEC/MANUAL AUTOIMMUNE KIT FOR HISTONE

K-Number: K962450 · 1996-11-25

ApplicantHycor Biomedical, Inc.
Decision Date1996-11-25
Product CodeLJM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

HY-TEC/MANUAL AUTOIMMUNE KIT FOR HISTONE 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 1996-11-25 under 510(k) number K962450. The device is classified under product code LJM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HY-TEC/MANUAL AUTOIMMUNE KIT FOR HISTONE?

HY-TEC/MANUAL AUTOIMMUNE KIT FOR HISTONE is a medical device that received FDA 510(k) clearance on 1996-11-25. The listed applicant is Hycor Biomedical, Inc.. The 510(k) number is K962450.

When did HY-TEC/MANUAL AUTOIMMUNE KIT FOR HISTONE receive FDA 510(k) clearance?

HY-TEC/MANUAL AUTOIMMUNE KIT FOR HISTONE received FDA 510(k) clearance on 1996-11-25, under 510(k) number K962450.

Who is the listed applicant for HY-TEC/MANUAL AUTOIMMUNE KIT FOR HISTONE?

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 HY-TEC/MANUAL AUTOIMMUNE KIT FOR HISTONE?

The FDA product code for HY-TEC/MANUAL AUTOIMMUNE KIT FOR HISTONE is LJM.

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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 DISCK962722HYCOR HY.TEC/MANUAL SM AUTO-ANTIBODY

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Related Devices (Code: LJM)

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.

K182353EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 ImmunoassayPhadia ABK151559ImmuLisa Enhanced Centromere Antibody ELISAImmco Diagnostics, Inc.K131185ANA SCREEN ELISA (IGG)Euroimmun USK083188VARELISA RECOMBI ANA SCREEN, MODEL 12 596Phadia US, Inc.K050967VARELISA RECOMBI CTD SCREEN, MODEL 13096Sweden Diagnostics (Germany) GmbHK050625VARELISA RECOMBI ANA PROFILE, MODEL 18496Sweden Diagnostics (Germany) GmbH

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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