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FDA 510(k)

ENZYMUNE-TEST T4

K-Number: K820750 · 1982-04-06

ApplicantIcl Scientific
Decision Date1982-04-06
Product CodeKLI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ENZYMUNE-TEST T4 is the device name listed in this FDA 510(k) record. The listed applicant is Icl Scientific. It received FDA 510(k) clearance on 1982-04-06 under 510(k) number K820750. The device is classified under product code KLI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENZYMUNE-TEST T4?

ENZYMUNE-TEST T4 is a medical device that received FDA 510(k) clearance on 1982-04-06. The listed applicant is Icl Scientific. The 510(k) number is K820750.

When did ENZYMUNE-TEST T4 receive FDA 510(k) clearance?

ENZYMUNE-TEST T4 received FDA 510(k) clearance on 1982-04-06, under 510(k) number K820750.

Who is the listed applicant for ENZYMUNE-TEST T4?

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 ENZYMUNE-TEST T4?

The FDA product code for ENZYMUNE-TEST T4 is KLI.

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Other records listing Icl Scientific 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.

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: KLI)

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.

K160495VITROS® Automation SolutionsOrtho-Clinical Diagnostics, Inc.K131515ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENTAlfa WassermannK103484GSP NEONATAL THYROXINE (T4)Wallac Oy, A Subsidiary of Perkinelmer, Inc.K082638ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELLSiemens Healthcare Diagnostics, Inc.K030860ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300MonobindK023369ACCESS TOTAL T4 ASSAYBeckman Coulter, 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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