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FDA 510(k)

H.PYLORI CONTROLS

K-Number: K964675 · 1997-01-27

ApplicantPyramid Biological Corp.
Decision Date1997-01-27
Product CodeLYR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

H.PYLORI 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 1997-01-27 under 510(k) number K964675. The device is classified under product code LYR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the H.PYLORI CONTROLS?

H.PYLORI CONTROLS is a medical device that received FDA 510(k) clearance on 1997-01-27. The listed applicant is Pyramid Biological Corp.. The 510(k) number is K964675.

When did H.PYLORI CONTROLS receive FDA 510(k) clearance?

H.PYLORI CONTROLS received FDA 510(k) clearance on 1997-01-27, under 510(k) number K964675.

Who is the listed applicant for H.PYLORI 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 H.PYLORI CONTROLS?

The FDA product code for H.PYLORI CONTROLS is LYR.

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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.

K962399HEPATITIS NEGATIVE CONTROLK961317SYPHILIS IGM HUMAN SERUM CONTROLSK960493SYPHILIS IGG HUMAN SERUM CONTROLSK954515ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLAK953826ENZYME LINKED UMMINOABSORBENT ASSAY, RUBELLAK952818ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII

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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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