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FDA 510(k)

LYPHOCHEK(R) TUMOR MARKER CONTROLS, LEVELS I & II

K-Number: K894078 · 1989-08-11

ApplicantBio-Rad
Decision Date1989-08-11
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LYPHOCHEK(R) TUMOR MARKER CONTROLS, LEVELS I & II is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1989-08-11 under 510(k) number K894078. 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(R) TUMOR MARKER CONTROLS, LEVELS I & II?

LYPHOCHEK(R) TUMOR MARKER CONTROLS, LEVELS I & II is a medical device that received FDA 510(k) clearance on 1989-08-11. The listed applicant is Bio-Rad. The 510(k) number is K894078.

When did LYPHOCHEK(R) TUMOR MARKER CONTROLS, LEVELS I & II receive FDA 510(k) clearance?

LYPHOCHEK(R) TUMOR MARKER CONTROLS, LEVELS I & II received FDA 510(k) clearance on 1989-08-11, under 510(k) number K894078.

Who is the listed applicant for LYPHOCHEK(R) TUMOR MARKER CONTROLS, LEVELS I & II?

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(R) TUMOR MARKER CONTROLS, LEVELS I & II?

The FDA product code for LYPHOCHEK(R) TUMOR MARKER CONTROLS, LEVELS I & II 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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