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FDA 510(k)

STRAT TOTAL THYROXINE FLUOROMET ENZYME IMMUNOASSAY

K-Number: K860421 · 1986-02-11

ApplicantAmerican Dade
Decision Date1986-02-11
Product CodeCDX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

STRAT TOTAL THYROXINE FLUOROMET ENZYME IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is American Dade. It received FDA 510(k) clearance on 1986-02-11 under 510(k) number K860421. The device is classified under product code CDX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRAT TOTAL THYROXINE FLUOROMET ENZYME IMMUNOASSAY?

STRAT TOTAL THYROXINE FLUOROMET ENZYME IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1986-02-11. The listed applicant is American Dade. The 510(k) number is K860421.

When did STRAT TOTAL THYROXINE FLUOROMET ENZYME IMMUNOASSAY receive FDA 510(k) clearance?

STRAT TOTAL THYROXINE FLUOROMET ENZYME IMMUNOASSAY received FDA 510(k) clearance on 1986-02-11, under 510(k) number K860421.

Who is the listed applicant for STRAT TOTAL THYROXINE FLUOROMET ENZYME IMMUNOASSAY?

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

What is the FDA product code for STRAT TOTAL THYROXINE FLUOROMET ENZYME IMMUNOASSAY?

The FDA product code for STRAT TOTAL THYROXINE FLUOROMET ENZYME IMMUNOASSAY is CDX.

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Other records listing American Dade 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.

K873051STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAYK873171STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAYK873052STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAYK872789PARAMAX URINE/CSF CALIBRATORK872195DATA-FI DIMERTEST LATEX ASSAYK872196AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III

View all 149 devices →

Related Devices (Code: CDX)

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.

K961490ELECSYS T4 ASSAYBoehringer Mannheim Corp.K954312ACTIVE THYROXINE RIADiagnostic Systems Laboratories, Inc.K943416DELFIA NEONATAL THYROXINE KITWallac OYK934384AXSYM(TM) TOTAL T4Abbott LaboratoriesK932980TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116Sigma Diagnostics, Inc.K933426STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNOBaxter Diagnostics, 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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