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FDA 510(k)

MIN-MOLECULE PTH BY RADIOIMMUNOASSAY

K-Number: K820228 · 1982-03-11

ApplicantImmuno Nuclear Corp.
Decision Date1982-03-11
Product CodeCEW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MIN-MOLECULE PTH BY RADIOIMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Immuno Nuclear Corp.. It received FDA 510(k) clearance on 1982-03-11 under 510(k) number K820228. 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 MIN-MOLECULE PTH BY RADIOIMMUNOASSAY?

MIN-MOLECULE PTH BY RADIOIMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1982-03-11. The listed applicant is Immuno Nuclear Corp.. The 510(k) number is K820228.

When did MIN-MOLECULE PTH BY RADIOIMMUNOASSAY receive FDA 510(k) clearance?

MIN-MOLECULE PTH BY RADIOIMMUNOASSAY received FDA 510(k) clearance on 1982-03-11, under 510(k) number K820228.

Who is the listed applicant for MIN-MOLECULE PTH BY RADIOIMMUNOASSAY?

The FDA 510(k) record lists Immuno Nuclear Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MIN-MOLECULE PTH BY RADIOIMMUNOASSAY?

The FDA product code for MIN-MOLECULE PTH BY RADIOIMMUNOASSAY is CEW.

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Other records listing Immuno Nuclear Corp. as applicant

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K863743BIOTECH'S IGE IMMUNO RESPONSE TEST ISOTOPE UNITK863973ELM ALLERGEN DISCK863844IMMUNO BIOTECH'S LAMB'S QUARTERS ALLERGEN DISCK863123IMMUNO BIOTECH MUGWART ALLERGEN DISCK863098MEADOW FESCUE ALLERGEN DISCK862266MAPLE ALLERGEN DISC

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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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