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FDA 510(k)

HEPATITIS NEGATIVE CONTROL

K-Number: K962399 · 1996-08-02

ApplicantPyramid Biological Corp.
Decision Date1996-08-02
Product CodeMJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HEPATITIS NEGATIVE CONTROL 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 1996-08-02 under 510(k) number K962399. The device is classified under product code MJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEPATITIS NEGATIVE CONTROL?

HEPATITIS NEGATIVE CONTROL is a medical device that received FDA 510(k) clearance on 1996-08-02. The listed applicant is Pyramid Biological Corp.. The 510(k) number is K962399.

When did HEPATITIS NEGATIVE CONTROL receive FDA 510(k) clearance?

HEPATITIS NEGATIVE CONTROL received FDA 510(k) clearance on 1996-08-02, under 510(k) number K962399.

Who is the listed applicant for HEPATITIS NEGATIVE CONTROL?

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 HEPATITIS NEGATIVE CONTROL?

The FDA product code for HEPATITIS NEGATIVE CONTROL is MJY.

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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 CONTROLSK961317SYPHILIS 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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