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FDA 510(k)

QUANTIMUNE HLH RIA HUMAN LUTENIZING HORM

K-Number: K810302 · 1981-02-25

ApplicantBio-Rad
Decision Date1981-02-25
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

QUANTIMUNE HLH RIA HUMAN LUTENIZING HORM is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1981-02-25 under 510(k) number K810302. The device is classified under product code CEP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUANTIMUNE HLH RIA HUMAN LUTENIZING HORM?

QUANTIMUNE HLH RIA HUMAN LUTENIZING HORM is a medical device that received FDA 510(k) clearance on 1981-02-25. The listed applicant is Bio-Rad. The 510(k) number is K810302.

When did QUANTIMUNE HLH RIA HUMAN LUTENIZING HORM receive FDA 510(k) clearance?

QUANTIMUNE HLH RIA HUMAN LUTENIZING HORM received FDA 510(k) clearance on 1981-02-25, under 510(k) number K810302.

Who is the listed applicant for QUANTIMUNE HLH RIA HUMAN LUTENIZING HORM?

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 QUANTIMUNE HLH RIA HUMAN LUTENIZING HORM?

The FDA product code for QUANTIMUNE HLH RIA HUMAN LUTENIZING HORM is CEP.

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: CEP)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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