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FDA 510(k)

HYCOR HY.TEC/MANUAL RF AUTO-ANTIBODY

K-Number: K962729 · 1997-03-07

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

Device Summary

HYCOR HY.TEC/MANUAL RF 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 K962729. The device is classified under product code DHR. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

HYCOR HY.TEC/MANUAL RF 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 K962729.

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

HYCOR HY.TEC/MANUAL RF AUTO-ANTIBODY received FDA 510(k) clearance on 1997-03-07, under 510(k) number K962729.

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

The FDA product code for HYCOR HY.TEC/MANUAL RF AUTO-ANTIBODY is DHR.

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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 DISCK962728HYCOR HY.TEC/MANUAL ENA AUTO-ANTIBODY

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Related Devices (Code: DHR)

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.

K192727K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)Kamiya Biomedical CompanyK190088QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA ReagentsInova Diagnostics, Inc.K182747EliA RF IgM ImmunoassayPhadia ABK162263Optilite Rheumatoid Factor KitThe Binding Site Group , Ltd.K160070Rheumatoid Factor (RF) Kit for use on SPAPLUSThe Binding Site Group , Ltd.K102673RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEMPhadia US, 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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