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FDA 510(k)

HYTEC AUTOMMUNE KIT (ENA)

K-Number: K954890 · 1995-12-26

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

Device Summary

HYTEC AUTOMMUNE KIT (ENA) 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 K954890. The device is classified under product code LLL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYTEC AUTOMMUNE KIT (ENA)?

HYTEC AUTOMMUNE KIT (ENA) 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 K954890.

When did HYTEC AUTOMMUNE KIT (ENA) receive FDA 510(k) clearance?

HYTEC AUTOMMUNE KIT (ENA) received FDA 510(k) clearance on 1995-12-26, under 510(k) number K954890.

Who is the listed applicant for HYTEC AUTOMMUNE KIT (ENA)?

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 AUTOMMUNE KIT (ENA)?

The FDA product code for HYTEC AUTOMMUNE KIT (ENA) is LLL.

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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: LLL)

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.

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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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