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FDA 510(k)

EMC-M-175, THYROXINE - 100 TUBES

K-Number: K800187 · 1980-02-13

ApplicantEndocrine-Metabolic Center
Decision Date1980-02-13
Product CodeCDX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EMC-M-175, THYROXINE - 100 TUBES is the device name listed in this FDA 510(k) record. The listed applicant is Endocrine-Metabolic Center. It received FDA 510(k) clearance on 1980-02-13 under 510(k) number K800187. 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 EMC-M-175, THYROXINE - 100 TUBES?

EMC-M-175, THYROXINE - 100 TUBES is a medical device that received FDA 510(k) clearance on 1980-02-13. The listed applicant is Endocrine-Metabolic Center. The 510(k) number is K800187.

When did EMC-M-175, THYROXINE - 100 TUBES receive FDA 510(k) clearance?

EMC-M-175, THYROXINE - 100 TUBES received FDA 510(k) clearance on 1980-02-13, under 510(k) number K800187.

Who is the listed applicant for EMC-M-175, THYROXINE - 100 TUBES?

The FDA 510(k) record lists Endocrine-Metabolic Center as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EMC-M-175, THYROXINE - 100 TUBES?

The FDA product code for EMC-M-175, THYROXINE - 100 TUBES is CDX.

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Other records listing Endocrine-Metabolic Center 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.

K821131RADIOIMMUNOASSAY PARATHYROID HORMONE MIDK811993RADIOIMMUNOASSAY, FOLLICLE STIMULATINGK811994RADIOIMMUNOASSAY LUTEINIZING HORMONEK810948RADIOIMMUNOASSAY THYROID STIM. HORM. KITK810351RADIOIMMUNOASSAY, TOTAL TRIIODOTHRONIEK800188EMC-M-180, T3 UPTAKE - 100 TUBES

View all 9 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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