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FDA 510(k)

MODIFIED DSL-2300 ACTH RIA

K-Number: K900147 · 1990-03-01

ApplicantDiagnostic Systems Laboratories, Inc.
Decision Date1990-03-01
Product CodeCKG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MODIFIED DSL-2300 ACTH RIA 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 1990-03-01 under 510(k) number K900147. The device is classified under product code CKG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFIED DSL-2300 ACTH RIA?

MODIFIED DSL-2300 ACTH RIA is a medical device that received FDA 510(k) clearance on 1990-03-01. The listed applicant is Diagnostic Systems Laboratories, Inc.. The 510(k) number is K900147.

When did MODIFIED DSL-2300 ACTH RIA receive FDA 510(k) clearance?

MODIFIED DSL-2300 ACTH RIA received FDA 510(k) clearance on 1990-03-01, under 510(k) number K900147.

Who is the listed applicant for MODIFIED DSL-2300 ACTH RIA?

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 MODIFIED DSL-2300 ACTH RIA?

The FDA product code for MODIFIED DSL-2300 ACTH RIA is CKG.

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Other records listing Diagnostic Systems Laboratories, Inc. as applicant

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K061758ACTIVE RENIN IRMAK020945AXSYM INTACT PTH, MODEL 2G06K020128ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500K002128ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100K001086FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900K990138DSL ACTIVE AFP ELISA, MODEL DSL-10-8400

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Related Devices (Code: CKG)

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.

K223867IDS ACTH IIImmunodiagnostic Systems LimitedK111335ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321Tosoh Bioscience, Inc.K060585ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTHRoche Diagnostics Corp.K050748ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011Scantibodies Laboratory, Inc.K021032ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100Scantibodies Laboratory, Inc.K002638FUTURE DIAGNOSTICS B.V. STAT-ACTH KITFuture Diagnostics B.V.

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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