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FDA 510(k)

CDM

K-Number: K960392 · 1996-07-08

ApplicantBio-Rad
Decision Date1996-07-08
Product CodeLDM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CDM is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1996-07-08 under 510(k) number K960392. 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 CDM?

CDM is a medical device that received FDA 510(k) clearance on 1996-07-08. The listed applicant is Bio-Rad. The 510(k) number is K960392.

When did CDM receive FDA 510(k) clearance?

CDM received FDA 510(k) clearance on 1996-07-08, under 510(k) number K960392.

Who is the listed applicant for CDM?

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 CDM?

The FDA product code for CDM is LDM.

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.

K171061MRSASelect IIK122187VRESELECT CULTURE MEDIUMK103684VRESELECT CULTURE MEDIUMK093678PLATELIA ASPERGILLUS EIA MODEL 62793K100589MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENSK081362PLATELIA LYME IGM

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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.

K961557ALLIANCE 2690 SEPARATIONS MODULEWaters CorporationK942451BIO-RAD CLINICAL DATA MANAGEMENT SYSTEMBio-RadK922388WATERS(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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