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FDA 510(k)

HUMAN CHORIONIC GONADOTROPIN (RIA)

K-Number: K792197 · 1979-12-06

ApplicantNuclear Medical Laboratories, Inc.
Decision Date1979-12-06
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HUMAN CHORIONIC GONADOTROPIN (RIA) is the device name listed in this FDA 510(k) record. The listed applicant is Nuclear Medical Laboratories, Inc.. It received FDA 510(k) clearance on 1979-12-06 under 510(k) number K792197. The device is classified under product code JHI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HUMAN CHORIONIC GONADOTROPIN (RIA)?

HUMAN CHORIONIC GONADOTROPIN (RIA) is a medical device that received FDA 510(k) clearance on 1979-12-06. The listed applicant is Nuclear Medical Laboratories, Inc.. The 510(k) number is K792197.

When did HUMAN CHORIONIC GONADOTROPIN (RIA) receive FDA 510(k) clearance?

HUMAN CHORIONIC GONADOTROPIN (RIA) received FDA 510(k) clearance on 1979-12-06, under 510(k) number K792197.

Who is the listed applicant for HUMAN CHORIONIC GONADOTROPIN (RIA)?

The FDA 510(k) record lists Nuclear Medical Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HUMAN CHORIONIC GONADOTROPIN (RIA)?

The FDA product code for HUMAN CHORIONIC GONADOTROPIN (RIA) is JHI.

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Other records listing Nuclear Medical Laboratories, Inc. as applicant

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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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