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FDA 510(k)

SOPHEIA CORTISOL EIA KIT

K-Number: K822845 · 1982-10-27

ApplicantDiagnostic Products Corp.
Decision Date1982-10-27
Product CodeCGR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SOPHEIA CORTISOL EIA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Products Corp.. It received FDA 510(k) clearance on 1982-10-27 under 510(k) number K822845. 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 SOPHEIA CORTISOL EIA KIT?

SOPHEIA CORTISOL EIA KIT is a medical device that received FDA 510(k) clearance on 1982-10-27. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K822845.

When did SOPHEIA CORTISOL EIA KIT receive FDA 510(k) clearance?

SOPHEIA CORTISOL EIA KIT received FDA 510(k) clearance on 1982-10-27, under 510(k) number K822845.

Who is the listed applicant for SOPHEIA CORTISOL EIA KIT?

The FDA 510(k) record lists Diagnostic Products Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOPHEIA CORTISOL EIA KIT?

The FDA product code for SOPHEIA CORTISOL EIA KIT is CGR.

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Other records listing Diagnostic Products Corp. 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.

K063045IMMULITE 2000, IMMULITE 2500 VANCOMYCINK034055IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN IK033234IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZERK032881IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONEK023152IMMULITE 2000 ALLERGEN-SPECIFIC IGEK023304IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL

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Related Devices (Code: CGR)

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.

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

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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