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FDA 510(k)

CMV IGG HUMAN SERUM CONTROLS

K-Number: K951800 · 1995-11-16

ApplicantPyramid Biological Corp.
Decision Date1995-11-16
Product CodeGQI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CMV IGG HUMAN SERUM CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is Pyramid Biological Corp.. It received FDA 510(k) clearance on 1995-11-16 under 510(k) number K951800. 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 CMV IGG HUMAN SERUM CONTROLS?

CMV IGG HUMAN SERUM CONTROLS is a medical device that received FDA 510(k) clearance on 1995-11-16. The listed applicant is Pyramid Biological Corp.. The 510(k) number is K951800.

When did CMV IGG HUMAN SERUM CONTROLS receive FDA 510(k) clearance?

CMV IGG HUMAN SERUM CONTROLS received FDA 510(k) clearance on 1995-11-16, under 510(k) number K951800.

Who is the listed applicant for CMV IGG HUMAN SERUM CONTROLS?

The FDA 510(k) record lists Pyramid Biological Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CMV IGG HUMAN SERUM CONTROLS?

The FDA product code for CMV IGG HUMAN SERUM CONTROLS is GQI.

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Other records listing Pyramid Biological Corp. 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.

K964675H.PYLORI CONTROLSK962399HEPATITIS NEGATIVE CONTROLK961317SYPHILIS IGM HUMAN SERUM CONTROLSK960493SYPHILIS IGG HUMAN SERUM CONTROLSK954515ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLAK953826ENZYME LINKED UMMINOABSORBENT ASSAY, RUBELLA

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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.

K952254ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUSPyramid Biological Corp.K942171CMV EARLY ANTIGEN TESTNeogenexK883102VIRGO (R) CMV-IGG ELISAElectro-Nucleonics, Inc.K875159DETECTADOT SYSTEM 2000 CMV IGG TESTGull Laboratories, 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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