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FDA 510(k)

RADIOIMMUNOASSAY PARATHYROID HORMONE MID

K-Number: K821131 · 1982-06-02

ApplicantEndocrine-Metabolic Center
Decision Date1982-06-02
Product CodeCEW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RADIOIMMUNOASSAY PARATHYROID HORMONE MID 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 1982-06-02 under 510(k) number K821131. The device is classified under product code CEW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADIOIMMUNOASSAY PARATHYROID HORMONE MID?

RADIOIMMUNOASSAY PARATHYROID HORMONE MID is a medical device that received FDA 510(k) clearance on 1982-06-02. The listed applicant is Endocrine-Metabolic Center. The 510(k) number is K821131.

When did RADIOIMMUNOASSAY PARATHYROID HORMONE MID receive FDA 510(k) clearance?

RADIOIMMUNOASSAY PARATHYROID HORMONE MID received FDA 510(k) clearance on 1982-06-02, under 510(k) number K821131.

Who is the listed applicant for RADIOIMMUNOASSAY PARATHYROID HORMONE MID?

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 RADIOIMMUNOASSAY PARATHYROID HORMONE MID?

The FDA product code for RADIOIMMUNOASSAY PARATHYROID HORMONE MID is CEW.

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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.

K811993RADIOIMMUNOASSAY, FOLLICLE STIMULATINGK811994RADIOIMMUNOASSAY LUTEINIZING HORMONEK810948RADIOIMMUNOASSAY THYROID STIM. HORM. KITK810351RADIOIMMUNOASSAY, TOTAL TRIIODOTHRONIEK800188EMC-M-180, T3 UPTAKE - 100 TUBESK800187EMC-M-175, THYROXINE - 100 TUBES

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Related Devices (Code: CEW)

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.

K231927Elecsys PTH , Elecsys PTH STATRoche DiagnosticsK232791Access Intact PTHBeckman Coulter, Inc.K221197VITROS Immunodiagnostic Products Intact PTH II Reagent PackOrtho Clinical DiagnosticsK190702Lumipulse G whole PTHFujirebio Diagnostics,Inc.K163658ADVIA Centaur Intact Parathyroid Hormone (PTH) AssaySiemens Healthcare Diagnostics, Inc.K161158IDS-iSYS Intact PTHNImmunodiagnostic Systems , Ltd.

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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