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FDA 510(k)

ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA

K-Number: K954515 · 1995-12-20

ApplicantPyramid Biological Corp.
Decision Date1995-12-20
Product CodeGOM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA 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 1995-12-20 under 510(k) number K954515. The device is classified under product code GOM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA?

ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA is a medical device that received FDA 510(k) clearance on 1995-12-20. The listed applicant is Pyramid Biological Corp.. The 510(k) number is K954515.

When did ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA receive FDA 510(k) clearance?

ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA received FDA 510(k) clearance on 1995-12-20, under 510(k) number K954515.

Who is the listed applicant for ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA?

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 ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA?

The FDA product code for ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA is GOM.

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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 CONTROLSK953826ENZYME LINKED UMMINOABSORBENT ASSAY, RUBELLAK952818ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII

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Related Devices (Code: GOM)

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.

K953826ENZYME LINKED UMMINOABSORBENT ASSAY, RUBELLAPyramid Biological 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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