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FDA 510(k)

ACTIVE LH IRMA

K-Number: K961109 · 1996-04-05

ApplicantDiagnostic Systems Laboratories, Inc.
Decision Date1996-04-05
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACTIVE LH IRMA 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 1996-04-05 under 510(k) number K961109. The device is classified under product code CEP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACTIVE LH IRMA?

ACTIVE LH IRMA is a medical device that received FDA 510(k) clearance on 1996-04-05. The listed applicant is Diagnostic Systems Laboratories, Inc.. The 510(k) number is K961109.

When did ACTIVE LH IRMA receive FDA 510(k) clearance?

ACTIVE LH IRMA received FDA 510(k) clearance on 1996-04-05, under 510(k) number K961109.

Who is the listed applicant for ACTIVE LH IRMA?

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 LH IRMA?

The FDA product code for ACTIVE LH IRMA is CEP.

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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: CEP)

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.

K013582MAYBE?MOM MINI OVULATION MICROSCOPEMaybe?MomK022829INSTANT-VIEW LH OVULATION PREDICTING TESTAlfa Scientific Designs, Inc.K021409AT HOME OVULATION TEST, MODEL 9032Phamatech, Inc.K013874CLEARPLANE EASY OVULATION TESTUnipath , Ltd.K013323TCI-31 LIFELONG OVULATION TESTERTci New YorkK012252QUIK-CHECK OVULATION PREDICTORACON Laboratories, Inc.

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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