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FDA 510(k)

DSL ERYTHROPOIETIN (DSL # 1100)

K-Number: K903492 · 1990-10-26

ApplicantDiagnostic Systems Laboratories, Inc.
Decision Date1990-10-26
Product CodeGGT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

DSL ERYTHROPOIETIN (DSL # 1100) 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 1990-10-26 under 510(k) number K903492. The device is classified under product code GGT. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DSL ERYTHROPOIETIN (DSL # 1100)?

DSL ERYTHROPOIETIN (DSL # 1100) is a medical device that received FDA 510(k) clearance on 1990-10-26. The listed applicant is Diagnostic Systems Laboratories, Inc.. The 510(k) number is K903492.

When did DSL ERYTHROPOIETIN (DSL # 1100) receive FDA 510(k) clearance?

DSL ERYTHROPOIETIN (DSL # 1100) received FDA 510(k) clearance on 1990-10-26, under 510(k) number K903492.

Who is the listed applicant for DSL ERYTHROPOIETIN (DSL # 1100)?

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 ERYTHROPOIETIN (DSL # 1100)?

The FDA product code for DSL ERYTHROPOIETIN (DSL # 1100) is GGT.

Related Clinical Trials

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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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.

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: GGT)

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.

K240182Access EPOBeckman Coulter, Inc.K183088ADVIA Centaur Erythropoietin (EPO) assayAxis-Shield Diagnostics LimitedK052223ACCESS EPO ASSAYBeckman Coulter, Inc.K992799SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KITSangui Biotech, Inc.K983203IMMULITE EPO, MODEL #'S LKEPZ & LKEP1Diagnostic Products Corp.K980737ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAYNichols Institute Diagnostics

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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