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FDA 510(k)

CORTISOL-SQUIBB RADIOIMMUNOASSAY KIT

K-Number: K820341 · 1982-03-04

ApplicantE. R. Squibb & Sons, Inc.
Decision Date1982-03-04
Product CodeCGR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CORTISOL-SQUIBB RADIOIMMUNOASSAY KIT 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 1982-03-04 under 510(k) number K820341. The device is classified under product code CGR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORTISOL-SQUIBB RADIOIMMUNOASSAY KIT?

CORTISOL-SQUIBB RADIOIMMUNOASSAY KIT is a medical device that received FDA 510(k) clearance on 1982-03-04. The listed applicant is E. R. Squibb & Sons, Inc.. The 510(k) number is K820341.

When did CORTISOL-SQUIBB RADIOIMMUNOASSAY KIT receive FDA 510(k) clearance?

CORTISOL-SQUIBB RADIOIMMUNOASSAY KIT received FDA 510(k) clearance on 1982-03-04, under 510(k) number K820341.

Who is the listed applicant for CORTISOL-SQUIBB RADIOIMMUNOASSAY KIT?

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

What is the FDA product code for CORTISOL-SQUIBB RADIOIMMUNOASSAY KIT?

The FDA product code for CORTISOL-SQUIBB RADIOIMMUNOASSAY KIT is CGR.

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Other records listing E. R. Squibb & Sons, Inc. as applicant

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K821494RIA STAT 16K820616ANGIOTENSIS I-SQUIBB RADIOIMMUNOASSAYK820340T3 UPTAKE-SQUIBB DIAGNOSTIC KITK811240SUR-FIT LOOP OSTOMY O.R. SETK811239SUR-FIT DISPOSABLE CONVEX INSERTK811160SUR-FIT IRRIGATION SLEEVE

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Related Devices (Code: CGR)

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K242190Access Cortisol; DxC 500i Clinical AnalyzerBeckman Coulter, Inc.K223038Access CortisolBeckman Coulter, Inc.K202136IDS CortisolImmunodiagnostic Systems , Ltd.K202826IMMULITE® 2000 CortisolSiemens Healthcare Diagnostics Products, Ltd.K203270IMMULITE/IMMULITE® 1000 CortisolSiemens Healthcare Diagnostics Products, Ltd.K062626CORTISOL ELISAIbl-Hamburg GmbH

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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