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FDA 510(k)

LYPHOCHEK UNASSAYED CHEM. CONTROL (HUMAN) I AND II

K-Number: K882486 · 1988-10-25

ApplicantBio-Rad
Decision Date1988-10-25
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LYPHOCHEK UNASSAYED CHEM. CONTROL (HUMAN) I AND 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 1988-10-25 under 510(k) number K882486. 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 CHEM. CONTROL (HUMAN) I AND II?

LYPHOCHEK UNASSAYED CHEM. CONTROL (HUMAN) I AND II is a medical device that received FDA 510(k) clearance on 1988-10-25. The listed applicant is Bio-Rad. The 510(k) number is K882486.

When did LYPHOCHEK UNASSAYED CHEM. CONTROL (HUMAN) I AND II receive FDA 510(k) clearance?

LYPHOCHEK UNASSAYED CHEM. CONTROL (HUMAN) I AND II received FDA 510(k) clearance on 1988-10-25, under 510(k) number K882486.

Who is the listed applicant for LYPHOCHEK UNASSAYED CHEM. CONTROL (HUMAN) I AND 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 UNASSAYED CHEM. CONTROL (HUMAN) I AND II?

The FDA product code for LYPHOCHEK UNASSAYED CHEM. CONTROL (HUMAN) I AND II is JJY.

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Related Devices (Code: JJY)

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.

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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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