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FDA 510(k)

GASTRIN RADIOIMMUNOASSAY TEST KIT

K-Number: K842965 · 1984-10-11

ApplicantSerono Diagnostics, Inc.
Decision Date1984-10-11
Product Code
DecisionSubstantially Equivalent

Device Summary

GASTRIN RADIOIMMUNOASSAY TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Serono Diagnostics, Inc.. It received FDA 510(k) clearance on 1984-10-11 under 510(k) number K842965. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GASTRIN RADIOIMMUNOASSAY TEST KIT?

GASTRIN RADIOIMMUNOASSAY TEST KIT is a medical device that received FDA 510(k) clearance on 1984-10-11. The listed applicant is Serono Diagnostics, Inc.. The 510(k) number is K842965.

When did GASTRIN RADIOIMMUNOASSAY TEST KIT receive FDA 510(k) clearance?

GASTRIN RADIOIMMUNOASSAY TEST KIT received FDA 510(k) clearance on 1984-10-11, under 510(k) number K842965.

Who is the listed applicant for GASTRIN RADIOIMMUNOASSAY TEST KIT?

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

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Other records listing Serono Diagnostics, 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.

K953598SERIES 9100 PLUS AUTOMATED DIFFERENTIAL HEMATOLOGY ANALYZERSK942051SR1 DHEA-S ENZYME IMMUNOASSAYK883085T3 UPTAKE SEROZYME ENZYME IMMUNO KT/MAG SOLID PHASK882340LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT,MAG SOL PHAK880388T3 SEROZYME ENZYMEIMMUNOASSAY KIT, MAG SOLID PHASEK874866T4 SEROZYME ENZYMEIMMUNOASSAY KIT/MAG. SOLID PHASE

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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