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FDA 510(k)

DETECTADOT TM SYSTEM 2000 CMV IGM TEST

K-Number: K893230 · 1989-12-18

ApplicantGull Laboratories, Inc.
Decision Date1989-12-18
Product CodeLFZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

DETECTADOT TM SYSTEM 2000 CMV IGM TEST is the device name listed in this FDA 510(k) record. The listed applicant is Gull Laboratories, Inc.. It received FDA 510(k) clearance on 1989-12-18 under 510(k) number K893230. The device is classified under product code LFZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DETECTADOT TM SYSTEM 2000 CMV IGM TEST?

DETECTADOT TM SYSTEM 2000 CMV IGM TEST is a medical device that received FDA 510(k) clearance on 1989-12-18. The listed applicant is Gull Laboratories, Inc.. The 510(k) number is K893230.

When did DETECTADOT TM SYSTEM 2000 CMV IGM TEST receive FDA 510(k) clearance?

DETECTADOT TM SYSTEM 2000 CMV IGM TEST received FDA 510(k) clearance on 1989-12-18, under 510(k) number K893230.

Who is the listed applicant for DETECTADOT TM SYSTEM 2000 CMV IGM TEST?

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

What is the FDA product code for DETECTADOT TM SYSTEM 2000 CMV IGM TEST?

The FDA product code for DETECTADOT TM SYSTEM 2000 CMV IGM TEST is LFZ.

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Other records listing Gull Laboratories, Inc. as applicant

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Related Devices (Code: LFZ)

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.

K220949Architect CMV IgGAbbott LaboratoriesK220911Elecsys CMV IgGRoche DiagnosticsK181213ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality ControlSiemens Healthcare Diagnostics, Inc.K163569Elecsys CMV IgMRoche DiagnosticsK162969LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control SetDiaSorin, Inc.K040290DIASORIN LIAISON CMV IGM/IGGDiasorin S.P.A

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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