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FDA 510(k)

LUMATAG(TM) HCG CHEMILUMINESCENCE IMMUNOMETRIC

K-Number: K901484 · 1990-05-01

ApplicantLondon Diagnostics, Inc.
Decision Date1990-05-01
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LUMATAG(TM) HCG CHEMILUMINESCENCE IMMUNOMETRIC 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 1990-05-01 under 510(k) number K901484. The device is classified under product code JHI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUMATAG(TM) HCG CHEMILUMINESCENCE IMMUNOMETRIC?

LUMATAG(TM) HCG CHEMILUMINESCENCE IMMUNOMETRIC is a medical device that received FDA 510(k) clearance on 1990-05-01. The listed applicant is London Diagnostics, Inc.. The 510(k) number is K901484.

When did LUMATAG(TM) HCG CHEMILUMINESCENCE IMMUNOMETRIC receive FDA 510(k) clearance?

LUMATAG(TM) HCG CHEMILUMINESCENCE IMMUNOMETRIC received FDA 510(k) clearance on 1990-05-01, under 510(k) number K901484.

Who is the listed applicant for LUMATAG(TM) HCG CHEMILUMINESCENCE IMMUNOMETRIC?

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) HCG CHEMILUMINESCENCE IMMUNOMETRIC?

The FDA product code for LUMATAG(TM) HCG CHEMILUMINESCENCE IMMUNOMETRIC is JHI.

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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: JHI)

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.

K262299Instant-View® hCG Combo II Cassette TestAlfa Scientific Designs, Inc.K241919Innovita HCG Pregnancy Rapid Combo TestInnovita (Tangshan) Biological Technology Co., Ltd.K203272Alltest Pregnancy Rapid Combo Test CassetteHangzhou AllTest Biotech Co., Ltd.K172322Atellica IM Total hCG (ThCG)Siemens Healthcare Diagnostics, Inc.K172257TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)True Diagnostics, Inc.K152768Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test StripAssure Tech. Co., Ltd.

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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