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FDA 510(k)

BIO-RAD CLINICAL DATA MANAGEMENT SYSTEM

K-Number: K942451 · 1994-11-10

ApplicantBio-Rad
Decision Date1994-11-10
Product CodeLDM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIO-RAD CLINICAL DATA MANAGEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1994-11-10 under 510(k) number K942451. The device is classified under product code LDM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIO-RAD CLINICAL DATA MANAGEMENT SYSTEM?

BIO-RAD CLINICAL DATA MANAGEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 1994-11-10. The listed applicant is Bio-Rad. The 510(k) number is K942451.

When did BIO-RAD CLINICAL DATA MANAGEMENT SYSTEM receive FDA 510(k) clearance?

BIO-RAD CLINICAL DATA MANAGEMENT SYSTEM received FDA 510(k) clearance on 1994-11-10, under 510(k) number K942451.

Who is the listed applicant for BIO-RAD CLINICAL DATA MANAGEMENT SYSTEM?

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 BIO-RAD CLINICAL DATA MANAGEMENT SYSTEM?

The FDA product code for BIO-RAD CLINICAL DATA MANAGEMENT SYSTEM is LDM.

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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.

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Related Devices (Code: LDM)

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.

K960392CDMBio-RadK961557ALLIANCE 2690 SEPARATIONS MODULEWaters CorporationK922388WATERS(TM) LC MODULE I FOR CLINICAL USEMillipore Corp.K920136WATERS 717 AUTOSAMPLERMillipore Corp.K903647MODULE 486 VARIABLE WAVELENGTH TUNABLE UV/VIS DETEMillipore Corp.K884886MODEL 250 LIQUID CHROMOTAGRAPHY PUMPThe Perkin-Elmer Corp.

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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