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FDA 510(k)

HISTIMUNE ENZYME-ANA TEST

K-Number: K822346 · 1982-10-08

ApplicantIcl Scientific
Decision Date1982-10-08
Product CodeLJM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

HISTIMUNE ENZYME-ANA TEST is the device name listed in this FDA 510(k) record. The listed applicant is Icl Scientific. It received FDA 510(k) clearance on 1982-10-08 under 510(k) number K822346. 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 HISTIMUNE ENZYME-ANA TEST?

HISTIMUNE ENZYME-ANA TEST is a medical device that received FDA 510(k) clearance on 1982-10-08. The listed applicant is Icl Scientific. The 510(k) number is K822346.

When did HISTIMUNE ENZYME-ANA TEST receive FDA 510(k) clearance?

HISTIMUNE ENZYME-ANA TEST received FDA 510(k) clearance on 1982-10-08, under 510(k) number K822346.

Who is the listed applicant for HISTIMUNE ENZYME-ANA TEST?

The FDA 510(k) record lists Icl Scientific as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HISTIMUNE ENZYME-ANA TEST?

The FDA product code for HISTIMUNE ENZYME-ANA TEST is LJM.

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Other records listing Icl Scientific as applicant

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K883942HYCOR SENTRY DRUGS OF ABUSE URINE CONTROLK843565KOVA TROL I,II, III HUMAN URINE-DRIEDK833761THERAPEUTIC DRUG CONTROLK832823ENZYMUNE-TEST TSHK831383EVENT-TEST SLIDEK823199ENZYME-TEST DIGOXIN

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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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