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FDA 510(k)

DSL 1020

K-Number: K821068 · 1982-05-05

ApplicantDiagnostic Systems Laboratories, Inc.
Decision Date1982-05-05
Product CodeCGR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DSL 1020 is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Systems Laboratories, Inc.. It received FDA 510(k) clearance on 1982-05-05 under 510(k) number K821068. 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 DSL 1020?

DSL 1020 is a medical device that received FDA 510(k) clearance on 1982-05-05. The listed applicant is Diagnostic Systems Laboratories, Inc.. The 510(k) number is K821068.

When did DSL 1020 receive FDA 510(k) clearance?

DSL 1020 received FDA 510(k) clearance on 1982-05-05, under 510(k) number K821068.

Who is the listed applicant for DSL 1020?

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

What is the FDA product code for DSL 1020?

The FDA product code for DSL 1020 is CGR.

Other records listing Diagnostic Systems Laboratories, 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.

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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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