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FDA 510(k)

HYTEC AUTOIMMUNE KITS (SM)

K-Number: K954896 · 1996-03-22

ApplicantHycor Biomedical, Inc.
Decision Date1996-03-22
Product CodeLKP
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

HYTEC AUTOIMMUNE KITS (SM) 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 1996-03-22 under 510(k) number K954896. The device is classified under product code LKP. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYTEC AUTOIMMUNE KITS (SM)?

HYTEC AUTOIMMUNE KITS (SM) is a medical device that received FDA 510(k) clearance on 1996-03-22. The listed applicant is Hycor Biomedical, Inc.. The 510(k) number is K954896.

When did HYTEC AUTOIMMUNE KITS (SM) receive FDA 510(k) clearance?

HYTEC AUTOIMMUNE KITS (SM) received FDA 510(k) clearance on 1996-03-22, under 510(k) number K954896.

Who is the listed applicant for HYTEC AUTOIMMUNE KITS (SM)?

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 AUTOIMMUNE KITS (SM)?

The FDA product code for HYTEC AUTOIMMUNE KITS (SM) is LKP.

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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: LKP)

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.

K202067EliA SmDP-SPhadia ABK183007EliA SmDP ImmunoassayPhadia ABK123593QUANTA FLASH SM, QUANTA FLASH RNP, QUANTA FLASH SM CALIBRATORS, QUANTA FLASH RNP CALIBRATORS, QUANTA FLASH SM CONTROLS,Inova Diagnostics, Inc.K051066THERATEST EL-ANA PROFILESTheratest Laboratories, Inc.K042629VARELISA SM ANTIBODIES, MODEL 18296Sweden Diagnostics (Germany) GmbHK024219LIQUICHEK ANTI-SM CONTROL, POSITIVE, CATALOG #115Bio-Rad

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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