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FDA 510(k)

RIA KIT, GLUCOSE

K-Number: K782143 · 1979-02-22

ApplicantSerono Laboratories, Inc.
Decision Date1979-02-22
Product CodeJME
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RIA KIT, GLUCOSE is the device name listed in this FDA 510(k) record. The listed applicant is Serono Laboratories, Inc.. It received FDA 510(k) clearance on 1979-02-22 under 510(k) number K782143. The device is classified under product code JME. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RIA KIT, GLUCOSE?

RIA KIT, GLUCOSE is a medical device that received FDA 510(k) clearance on 1979-02-22. The listed applicant is Serono Laboratories, Inc.. The 510(k) number is K782143.

When did RIA KIT, GLUCOSE receive FDA 510(k) clearance?

RIA KIT, GLUCOSE received FDA 510(k) clearance on 1979-02-22, under 510(k) number K782143.

Who is the listed applicant for RIA KIT, GLUCOSE?

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

What is the FDA product code for RIA KIT, GLUCOSE?

The FDA product code for RIA KIT, GLUCOSE is JME.

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Other records listing Serono Laboratories, Inc. as applicant

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Related Devices (Code: JME)

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.

K893975DOUBLE ANTIBODY GLUCAGONDiagnostic Products Corp.K771948GLUCAGON RIA MODULEInter Science Institute

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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