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FDA 510(k)

STRATUS FREE THYROXINE (FT4) FLUOR. ENZYME IMMUNO.

K-Number: K870158 · 1987-03-19

ApplicantAmerican Dade
Decision Date1987-03-19
Product CodeCEC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

STRATUS FREE THYROXINE (FT4) FLUOR. ENZYME IMMUNO. is the device name listed in this FDA 510(k) record. The listed applicant is American Dade. It received FDA 510(k) clearance on 1987-03-19 under 510(k) number K870158. The device is classified under product code CEC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRATUS FREE THYROXINE (FT4) FLUOR. ENZYME IMMUNO.?

STRATUS FREE THYROXINE (FT4) FLUOR. ENZYME IMMUNO. is a medical device that received FDA 510(k) clearance on 1987-03-19. The listed applicant is American Dade. The 510(k) number is K870158.

When did STRATUS FREE THYROXINE (FT4) FLUOR. ENZYME IMMUNO. receive FDA 510(k) clearance?

STRATUS FREE THYROXINE (FT4) FLUOR. ENZYME IMMUNO. received FDA 510(k) clearance on 1987-03-19, under 510(k) number K870158.

Who is the listed applicant for STRATUS FREE THYROXINE (FT4) FLUOR. ENZYME IMMUNO.?

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 STRATUS FREE THYROXINE (FT4) FLUOR. ENZYME IMMUNO.?

The FDA product code for STRATUS FREE THYROXINE (FT4) FLUOR. ENZYME IMMUNO. is CEC.

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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: CEC)

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.

K240273Access Free T4Beckman Coulter, Inc.K220456Elecsys FT4 IVRoche DiagnosticsK182423MAGLUMI 2000 FT4Shenzhen New Industries Biomedical Engineering Co., Ltd.K181233Elecsys FT4 IIIRoche DiagnosticsK173122Abbott Architect Free T4Abbott LaboratoriesK152422FREND™ Free T4 Test SystemNanoentek USA, 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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