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FDA 510(k)

DSL 1400

K-Number: K822314 · 1982-09-30

ApplicantDiagnostic Systems Laboratories, Inc.
Decision Date1982-09-30
Product CodeCGI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DSL 1400 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 1982-09-30 under 510(k) number K822314. 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 1400?

DSL 1400 is a medical device that received FDA 510(k) clearance on 1982-09-30. The listed applicant is Diagnostic Systems Laboratories, Inc.. The 510(k) number is K822314.

When did DSL 1400 receive FDA 510(k) clearance?

DSL 1400 received FDA 510(k) clearance on 1982-09-30, under 510(k) number K822314.

Who is the listed applicant for DSL 1400?

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 1400?

The FDA product code for DSL 1400 is CGI.

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: 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.

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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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