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FDA 510(k)

ALLEGRO INTACT PARATHYROID HORMONE IMMUNOASSAY

K-Number: K861797 · 1986-07-22

ApplicantNichols Institute Diagnostics
Decision Date1986-07-22
Product CodeCEW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALLEGRO INTACT PARATHYROID HORMONE IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Nichols Institute Diagnostics. It received FDA 510(k) clearance on 1986-07-22 under 510(k) number K861797. 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 ALLEGRO INTACT PARATHYROID HORMONE IMMUNOASSAY?

ALLEGRO INTACT PARATHYROID HORMONE IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1986-07-22. The listed applicant is Nichols Institute Diagnostics. The 510(k) number is K861797.

When did ALLEGRO INTACT PARATHYROID HORMONE IMMUNOASSAY receive FDA 510(k) clearance?

ALLEGRO INTACT PARATHYROID HORMONE IMMUNOASSAY received FDA 510(k) clearance on 1986-07-22, under 510(k) number K861797.

Who is the listed applicant for ALLEGRO INTACT PARATHYROID HORMONE IMMUNOASSAY?

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

What is the FDA product code for ALLEGRO INTACT PARATHYROID HORMONE IMMUNOASSAY?

The FDA product code for ALLEGRO INTACT PARATHYROID HORMONE IMMUNOASSAY is CEW.

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Other records listing Nichols Institute Diagnostics 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.

K050784NICHOLS ADVANTAGE ALDOSTERONE ASSAYK042676NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAYK042689NICHOLS ADVANTAGE CORTISOLK040813NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE, MODEL 62-7022K033727NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAYK033302NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040

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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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