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FDA 510(k)

HYTEC AUTOMIMMUNE KIT (RF)

K-Number: K954892 · 1995-12-26

ApplicantHycor Biomedical, Inc.
Decision Date1995-12-26
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

HYTEC AUTOMIMMUNE KIT (RF) 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 1995-12-26 under 510(k) number K954892. 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 HYTEC AUTOMIMMUNE KIT (RF)?

HYTEC AUTOMIMMUNE KIT (RF) is a medical device that received FDA 510(k) clearance on 1995-12-26. The listed applicant is Hycor Biomedical, Inc.. The 510(k) number is K954892.

When did HYTEC AUTOMIMMUNE KIT (RF) receive FDA 510(k) clearance?

HYTEC AUTOMIMMUNE KIT (RF) received FDA 510(k) clearance on 1995-12-26, under 510(k) number K954892.

Who is the listed applicant for HYTEC AUTOMIMMUNE KIT (RF)?

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 HYTEC AUTOMIMMUNE KIT (RF)?

The FDA product code for HYTEC AUTOMIMMUNE KIT (RF) 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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