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FDA 510(k)

DETECTADOT SYSTEM 2000 CMV IGG TEST

K-Number: K875159 · 1988-05-06

ApplicantGull Laboratories, Inc.
Decision Date1988-05-06
Product CodeGQI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

DETECTADOT SYSTEM 2000 CMV IGG 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 1988-05-06 under 510(k) number K875159. The device is classified under product code GQI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DETECTADOT SYSTEM 2000 CMV IGG TEST?

DETECTADOT SYSTEM 2000 CMV IGG TEST is a medical device that received FDA 510(k) clearance on 1988-05-06. The listed applicant is Gull Laboratories, Inc.. The 510(k) number is K875159.

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

DETECTADOT SYSTEM 2000 CMV IGG TEST received FDA 510(k) clearance on 1988-05-06, under 510(k) number K875159.

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

The FDA product code for DETECTADOT SYSTEM 2000 CMV IGG TEST is GQI.

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Other records listing Gull 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.

K983541HSV 1+2 IGG ELISA TESTK971857MUMPS IGG ELISA TESTYK962343TOXO IGG ELISA TESTK935730EBNA IGG ELISA TESTK940093EBV-EA(D) IGG ELISA TESTK941046VZV IGG ELISA TEST

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Related Devices (Code: GQI)

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.

K951800CMV IGG HUMAN SERUM CONTROLSPyramid Biological Corp.K952254ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUSPyramid Biological Corp.K942171CMV EARLY ANTIGEN TESTNeogenexK883102VIRGO (R) CMV-IGG ELISAElectro-Nucleonics, Inc.K863488ENZYGNOST ANTI-CMV IGG TESTBehring Diagnostics, Inc.K861123THE GOLDEN QUAD TEST (CMV)Microbiological Research 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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