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FDA 510(k)

GASTRIN 1-17 BY RADIOIMMUNOASSAY KIT

K-Number: K812727 · 1981-11-05

ApplicantImmuno Nuclear Corp.
Decision Date1981-11-05
Product CodeCGC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GASTRIN 1-17 BY RADIOIMMUNOASSAY KIT 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 1981-11-05 under 510(k) number K812727. The device is classified under product code CGC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GASTRIN 1-17 BY RADIOIMMUNOASSAY KIT?

GASTRIN 1-17 BY RADIOIMMUNOASSAY KIT is a medical device that received FDA 510(k) clearance on 1981-11-05. The listed applicant is Immuno Nuclear Corp.. The 510(k) number is K812727.

When did GASTRIN 1-17 BY RADIOIMMUNOASSAY KIT receive FDA 510(k) clearance?

GASTRIN 1-17 BY RADIOIMMUNOASSAY KIT received FDA 510(k) clearance on 1981-11-05, under 510(k) number K812727.

Who is the listed applicant for GASTRIN 1-17 BY RADIOIMMUNOASSAY KIT?

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 GASTRIN 1-17 BY RADIOIMMUNOASSAY KIT?

The FDA product code for GASTRIN 1-17 BY RADIOIMMUNOASSAY KIT is CGC.

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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: CGC)

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.

K961276GASTRIN EIA MODEL 06B-555017Biosyn , Ltd.K842079GASTRIN 34 HORMONE BY RADIOUMMUNOASSAYImmuno Nuclear Corp.K841963GASTRIN RIASyncor Intl. Corp.K833489DPC GASTRIN KITDiagnostic Products Corp.K831075BLOOD GAS & FLAME PHOTOMETER INSTRU-United Diagnostics, Inc.K821175GASTRIN RADIOIMMUNOASSAY KIT (125-I)Bd Becton Dickinson Vacutainer Systems Preanalytic

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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