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FDA 510(k)

ASSAY SYSTEM, GAMMAFLO, AUTOMATED

K-Number: K781659 · 1978-10-24

ApplicantE. R. Squibb & Sons, Inc.
Decision Date1978-10-24
Product Code
DecisionSubstantially Equivalent

Device Summary

ASSAY SYSTEM, GAMMAFLO, AUTOMATED is the device name listed in this FDA 510(k) record. The listed applicant is E. R. Squibb & Sons, Inc.. It received FDA 510(k) clearance on 1978-10-24 under 510(k) number K781659. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASSAY SYSTEM, GAMMAFLO, AUTOMATED?

ASSAY SYSTEM, GAMMAFLO, AUTOMATED is a medical device that received FDA 510(k) clearance on 1978-10-24. The listed applicant is E. R. Squibb & Sons, Inc.. The 510(k) number is K781659.

When did ASSAY SYSTEM, GAMMAFLO, AUTOMATED receive FDA 510(k) clearance?

ASSAY SYSTEM, GAMMAFLO, AUTOMATED received FDA 510(k) clearance on 1978-10-24, under 510(k) number K781659.

Who is the listed applicant for ASSAY SYSTEM, GAMMAFLO, AUTOMATED?

The FDA 510(k) record lists E. R. Squibb & Sons, Inc. as the applicant. This does not by itself establish the device manufacturer.

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Other records listing E. R. Squibb & Sons, 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.

K821494RIA STAT 16K820616ANGIOTENSIS I-SQUIBB RADIOIMMUNOASSAYK820341CORTISOL-SQUIBB RADIOIMMUNOASSAY KITK820340T3 UPTAKE-SQUIBB DIAGNOSTIC KITK811240SUR-FIT LOOP OSTOMY O.R. SETK811239SUR-FIT DISPOSABLE CONVEX INSERT

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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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