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FDA 510(k)

ACTIVE ULTRA-SENSITIVE UNCONJUGATED ESTRIOL

K-Number: K955356 · 1996-05-15

ApplicantDiagnostic Systems Laboratories, Inc.
Decision Date1996-05-15
Product CodeCGI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACTIVE ULTRA-SENSITIVE UNCONJUGATED ESTRIOL 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 1996-05-15 under 510(k) number K955356. 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 ACTIVE ULTRA-SENSITIVE UNCONJUGATED ESTRIOL?

ACTIVE ULTRA-SENSITIVE UNCONJUGATED ESTRIOL is a medical device that received FDA 510(k) clearance on 1996-05-15. The listed applicant is Diagnostic Systems Laboratories, Inc.. The 510(k) number is K955356.

When did ACTIVE ULTRA-SENSITIVE UNCONJUGATED ESTRIOL receive FDA 510(k) clearance?

ACTIVE ULTRA-SENSITIVE UNCONJUGATED ESTRIOL received FDA 510(k) clearance on 1996-05-15, under 510(k) number K955356.

Who is the listed applicant for ACTIVE ULTRA-SENSITIVE UNCONJUGATED ESTRIOL?

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 ACTIVE ULTRA-SENSITIVE UNCONJUGATED ESTRIOL?

The FDA product code for ACTIVE ULTRA-SENSITIVE UNCONJUGATED ESTRIOL is CGI.

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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: 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.K932989COAT-A-COUNT FREE ESTRIOLDiagnostic Products Corp.K944490AUTODELFIA UNCONJUGATED ESTRIOL (UE3) KITWallac OYK920576AMERLEX-M HIGH SENSITIVITY UNCONJUGATED ESTRIOLEastman Kodak CompanyK903359MICROZYME UNCONJUGATED ESTRIOL ENZYME IMMUNO KITImmunotech Corp.

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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