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FDA 510(k)

LUMATAG(TM) LH DIAGNOSTIC KIT

K-Number: K902443 · 1990-08-02

ApplicantLondon Diagnostics, Inc.
Decision Date1990-08-02
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LUMATAG(TM) LH DIAGNOSTIC KIT is the device name listed in this FDA 510(k) record. The listed applicant is London Diagnostics, Inc.. It received FDA 510(k) clearance on 1990-08-02 under 510(k) number K902443. 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 LUMATAG(TM) LH DIAGNOSTIC KIT?

LUMATAG(TM) LH DIAGNOSTIC KIT is a medical device that received FDA 510(k) clearance on 1990-08-02. The listed applicant is London Diagnostics, Inc.. The 510(k) number is K902443.

When did LUMATAG(TM) LH DIAGNOSTIC KIT receive FDA 510(k) clearance?

LUMATAG(TM) LH DIAGNOSTIC KIT received FDA 510(k) clearance on 1990-08-02, under 510(k) number K902443.

Who is the listed applicant for LUMATAG(TM) LH DIAGNOSTIC KIT?

The FDA 510(k) record lists London Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LUMATAG(TM) LH DIAGNOSTIC KIT?

The FDA product code for LUMATAG(TM) LH DIAGNOSTIC KIT is CEP.

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Other records listing London Diagnostics, 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.

K914835LUMATAG FREE T4 CHEMILUMINESCENCE ASSAYK911985LUMATAG T4 CHEMILUMINESCENCE ASSAYK912858LONDON DIAGNOSTICS LUMATAG(R) HGH CHEM IMMUN ASSAYK905814LUMATAG(R) FSH CHEMILUMINESCENCE IMMUNOMETRI ASSAYK904458LUMATAG(TM) PROLACTIN DIAGNOSTIC KIT/MODIFICATIONK903130LONDON DIAGNOSTICS LUMATAG(TM) INTACT PTH ASSAY

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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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