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FDA 510(k)

LYPHOCHEK UNASSAYED CHEMISTRY CONTROL LEVEL 3

K-Number: K922046 · 1992-07-10

ApplicantBio-Rad
Decision Date1992-07-10
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LYPHOCHEK UNASSAYED CHEMISTRY CONTROL LEVEL 3 is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1992-07-10 under 510(k) number K922046. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LYPHOCHEK UNASSAYED CHEMISTRY CONTROL LEVEL 3?

LYPHOCHEK UNASSAYED CHEMISTRY CONTROL LEVEL 3 is a medical device that received FDA 510(k) clearance on 1992-07-10. The listed applicant is Bio-Rad. The 510(k) number is K922046.

When did LYPHOCHEK UNASSAYED CHEMISTRY CONTROL LEVEL 3 receive FDA 510(k) clearance?

LYPHOCHEK UNASSAYED CHEMISTRY CONTROL LEVEL 3 received FDA 510(k) clearance on 1992-07-10, under 510(k) number K922046.

Who is the listed applicant for LYPHOCHEK UNASSAYED CHEMISTRY CONTROL LEVEL 3?

The FDA 510(k) record lists Bio-Rad as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LYPHOCHEK UNASSAYED CHEMISTRY CONTROL LEVEL 3?

The FDA product code for LYPHOCHEK UNASSAYED CHEMISTRY CONTROL LEVEL 3 is JJY.

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Related Devices (Code: JJY)

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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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