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FDA 510(k)

SYPHILIS IGG HUMAN SERUM CONTROLS

K-Number: K960493 · 1996-06-17

ApplicantPyramid Biological Corp.
Decision Date1996-06-17
Product CodeLIP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SYPHILIS 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 1996-06-17 under 510(k) number K960493. The device is classified under product code LIP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYPHILIS IGG HUMAN SERUM CONTROLS?

SYPHILIS IGG HUMAN SERUM CONTROLS is a medical device that received FDA 510(k) clearance on 1996-06-17. The listed applicant is Pyramid Biological Corp.. The 510(k) number is K960493.

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

SYPHILIS IGG HUMAN SERUM CONTROLS received FDA 510(k) clearance on 1996-06-17, under 510(k) number K960493.

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

The FDA product code for SYPHILIS IGG HUMAN SERUM CONTROLS is LIP.

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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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