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FDA 510(k)

ENZYM-LINKED T3

K-Number: K820763 · 1982-04-15

ApplicantIcl Scientific
Decision Date1982-04-15
Product CodeCDP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ENZYM-LINKED T3 is the device name listed in this FDA 510(k) record. The listed applicant is Icl Scientific. It received FDA 510(k) clearance on 1982-04-15 under 510(k) number K820763. The device is classified under product code CDP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENZYM-LINKED T3?

ENZYM-LINKED T3 is a medical device that received FDA 510(k) clearance on 1982-04-15. The listed applicant is Icl Scientific. The 510(k) number is K820763.

When did ENZYM-LINKED T3 receive FDA 510(k) clearance?

ENZYM-LINKED T3 received FDA 510(k) clearance on 1982-04-15, under 510(k) number K820763.

Who is the listed applicant for ENZYM-LINKED T3?

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 ENZYM-LINKED T3?

The FDA product code for ENZYM-LINKED T3 is CDP.

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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: CDP)

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.

K001607REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104)Repromedix Corp.K991692CHIRON DIAGNOSTICS ACS: 180 FT3Chiron Diagnostics Corp.K991311TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005Biocheck, Inc.K991252AIA-PACK FT3 ASSAYTosoh Medics, Inc.K981824OPTICOAT T3 EIA KITBiotecx Laboratories, Inc.K983439ABBOTT ARCHITECT FREE T3Abbott Laboratories

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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