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FDA 510(k)

IN VITRO GENTAMICIN RADIOIMMUNOASSY TEST

K-Number: K780709 · 1978-05-12

ApplicantClinical Assays, Inc.
Decision Date1978-05-12
Product Code
DecisionSubstantially Equivalent

Device Summary

IN VITRO GENTAMICIN RADIOIMMUNOASSY TEST is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Assays, Inc.. It received FDA 510(k) clearance on 1978-05-12 under 510(k) number K780709. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IN VITRO GENTAMICIN RADIOIMMUNOASSY TEST?

IN VITRO GENTAMICIN RADIOIMMUNOASSY TEST is a medical device that received FDA 510(k) clearance on 1978-05-12. The listed applicant is Clinical Assays, Inc.. The 510(k) number is K780709.

When did IN VITRO GENTAMICIN RADIOIMMUNOASSY TEST receive FDA 510(k) clearance?

IN VITRO GENTAMICIN RADIOIMMUNOASSY TEST received FDA 510(k) clearance on 1978-05-12, under 510(k) number K780709.

Who is the listed applicant for IN VITRO GENTAMICIN RADIOIMMUNOASSY TEST?

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

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Other records listing Clinical Assays, Inc. 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.

K832711VITAMIN B12 FOLATE CA-1515-125K832710VITAMIN B12 RADIOASSAY KIT CA-1534K832712FOLATE RADIOASSAY KIT CA-1562-125K823476GAMMADAB LH RADIO-KIT #CA-1508K823313IN VITRO GAMMACOAT B-HCG RADIO. TESTK821611GAMMADAB [125] FSH RADIOIMMUNAY KIT

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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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