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FDA 510(k)

INTACT PARATHYROID HORMONE (PTH) IMMUNOASSAY (MODIFICATION)

K-Number: K954418 · 1995-11-03

ApplicantNichols Institute Diagnostics
Decision Date1995-11-03
Product CodeCEW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

INTACT PARATHYROID HORMONE (PTH) IMMUNOASSAY (MODIFICATION) 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 1995-11-03 under 510(k) number K954418. 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 INTACT PARATHYROID HORMONE (PTH) IMMUNOASSAY (MODIFICATION)?

INTACT PARATHYROID HORMONE (PTH) IMMUNOASSAY (MODIFICATION) is a medical device that received FDA 510(k) clearance on 1995-11-03. The listed applicant is Nichols Institute Diagnostics. The 510(k) number is K954418.

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

INTACT PARATHYROID HORMONE (PTH) IMMUNOASSAY (MODIFICATION) received FDA 510(k) clearance on 1995-11-03, under 510(k) number K954418.

Who is the listed applicant for INTACT PARATHYROID HORMONE (PTH) IMMUNOASSAY (MODIFICATION)?

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 INTACT PARATHYROID HORMONE (PTH) IMMUNOASSAY (MODIFICATION)?

The FDA product code for INTACT PARATHYROID HORMONE (PTH) IMMUNOASSAY (MODIFICATION) 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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