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FDA 510(k)

DSL INSULIN RIA (DSL 1600)

K-Number: K914820 · 1992-01-09

ApplicantDiagnostic Systems Laboratories, Inc.
Decision Date1992-01-09
Product CodeCFP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DSL INSULIN RIA (DSL 1600) 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 1992-01-09 under 510(k) number K914820. The device is classified under product code CFP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DSL INSULIN RIA (DSL 1600)?

DSL INSULIN RIA (DSL 1600) is a medical device that received FDA 510(k) clearance on 1992-01-09. The listed applicant is Diagnostic Systems Laboratories, Inc.. The 510(k) number is K914820.

When did DSL INSULIN RIA (DSL 1600) receive FDA 510(k) clearance?

DSL INSULIN RIA (DSL 1600) received FDA 510(k) clearance on 1992-01-09, under 510(k) number K914820.

Who is the listed applicant for DSL INSULIN RIA (DSL 1600)?

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 INSULIN RIA (DSL 1600)?

The FDA product code for DSL INSULIN RIA (DSL 1600) is CFP.

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: CFP)

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.

K963911ALPCO/MERCODIA INSULIN ELISAAmerican Laboratory Products Co., Ltd.K953084ACCESS ULTRASENSITIVE INSULIN ASSAYBio-Rad Laboratories, Inc.K920109IMX INSULINAbbott LaboratoriesK903628AIA-PACK IRITosoh Corp.K901135ENZYMUN TEST(R) INSULINBoehringer Mannheim Corp.K896572REP(TM) SPE PLUS-30 PROCEDURESHelena Laboratories

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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