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FDA 510(k)

DSL 1900

K-Number: K830816 · 1983-04-12

ApplicantDiagnostic Systems
Decision Date1983-04-12
Product CodeCGI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DSL 1900 is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Systems. It received FDA 510(k) clearance on 1983-04-12 under 510(k) number K830816. The device is classified under product code CGI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DSL 1900?

DSL 1900 is a medical device that received FDA 510(k) clearance on 1983-04-12. The listed applicant is Diagnostic Systems. The 510(k) number is K830816.

When did DSL 1900 receive FDA 510(k) clearance?

DSL 1900 received FDA 510(k) clearance on 1983-04-12, under 510(k) number K830816.

Who is the listed applicant for DSL 1900?

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

What is the FDA product code for DSL 1900?

The FDA product code for DSL 1900 is CGI.

Other records listing Diagnostic Systems 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.

K905146OLYMPUS URINE PHK893691EMDS CREATINE KINASE ITEM NIMBER 65411K893692EMDS ASPARTATE AMINOTRANSFERASE ITEM NUMBER 65405K893966HDL PRECIPITATING REAGENTK884993VISUAL BLOOD GLUCOSE TEST SYSTEMK881116EASY-TEST EMIT(R) LIDOCAINE LIDO ITEM NO. 16641

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Related Devices (Code: CGI)

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.

K974721UNCONJUGATED ESTRIOL ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)Bayer Corp.K962875ACTIVE ULTRASENSITIVE UNCONJUGATED ESTRIOL EIADiagnostic Systems Laboratories, Inc.K955356ACTIVE ULTRA-SENSITIVE UNCONJUGATED ESTRIOLDiagnostic Systems Laboratories, Inc.K932989COAT-A-COUNT FREE ESTRIOLDiagnostic Products Corp.K944490AUTODELFIA UNCONJUGATED ESTRIOL (UE3) KITWallac OYK920576AMERLEX-M HIGH SENSITIVITY UNCONJUGATED ESTRIOLEastman Kodak Company

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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