Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

LYPHOCHEK SERUM REF. STANDARD-BOVINE

K-Number: K832695 · 1983-10-04

ApplicantBio-Rad
Decision Date1983-10-04
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LYPHOCHEK SERUM REF. STANDARD-BOVINE is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1983-10-04 under 510(k) number K832695. The device is classified under product code JIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LYPHOCHEK SERUM REF. STANDARD-BOVINE?

LYPHOCHEK SERUM REF. STANDARD-BOVINE is a medical device that received FDA 510(k) clearance on 1983-10-04. The listed applicant is Bio-Rad. The 510(k) number is K832695.

When did LYPHOCHEK SERUM REF. STANDARD-BOVINE receive FDA 510(k) clearance?

LYPHOCHEK SERUM REF. STANDARD-BOVINE received FDA 510(k) clearance on 1983-10-04, under 510(k) number K832695.

Who is the listed applicant for LYPHOCHEK SERUM REF. STANDARD-BOVINE?

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 SERUM REF. STANDARD-BOVINE?

The FDA product code for LYPHOCHEK SERUM REF. STANDARD-BOVINE is JIX.

Related Clinical Trials

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.

Other records listing Bio-Rad 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.

View all 319 devices →

Related Devices (Code: JIX)

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.

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.

↑