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FDA 510(k)

CDS LTX CONTROL LATEX PARTICLE SUSPENSION AND PRIMER

K-Number: K993375 · 1999-12-20

ApplicantClinical Diagnostic Solutions, Inc.
Decision Date1999-12-20
Product CodeKRX
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CDS LTX CONTROL LATEX PARTICLE SUSPENSION AND PRIMER is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Diagnostic Solutions, Inc.. It received FDA 510(k) clearance on 1999-12-20 under 510(k) number K993375. The device is classified under product code KRX. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CDS LTX CONTROL LATEX PARTICLE SUSPENSION AND PRIMER?

CDS LTX CONTROL LATEX PARTICLE SUSPENSION AND PRIMER is a medical device that received FDA 510(k) clearance on 1999-12-20. The listed applicant is Clinical Diagnostic Solutions, Inc.. The 510(k) number is K993375.

When did CDS LTX CONTROL LATEX PARTICLE SUSPENSION AND PRIMER receive FDA 510(k) clearance?

CDS LTX CONTROL LATEX PARTICLE SUSPENSION AND PRIMER received FDA 510(k) clearance on 1999-12-20, under 510(k) number K993375.

Who is the listed applicant for CDS LTX CONTROL LATEX PARTICLE SUSPENSION AND PRIMER?

The FDA 510(k) record lists Clinical Diagnostic Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CDS LTX CONTROL LATEX PARTICLE SUSPENSION AND PRIMER?

The FDA product code for CDS LTX CONTROL LATEX PARTICLE SUSPENSION AND PRIMER is KRX.

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.

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Other records listing Clinical Diagnostic Solutions, Inc. 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.

K041130CDS HEMATOLOGY CALIBRATOR (CDS CAL)K024173CDS 3-PD HEMATOLOGY CONTROLS

Related Devices (Code: KRX)

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.

K160585XN CALStreckK120747XN CAL PFStreckK120745XN CALStreckK111204CELL-DYN 22 PLUS CALIBRATORStreckK083200X-CALStreckK020469CAL-CHEX CD PLUSStreck Laboratories, Inc.

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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