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FDA 510(k)

PULSE CRP TEST

K-Number: K923768 · 1992-12-01

ApplicantPulse Scientific, Inc.
Decision Date1992-12-01
Product CodeDCK
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

PULSE CRP TEST is the device name listed in this FDA 510(k) record. The listed applicant is Pulse Scientific, Inc.. It received FDA 510(k) clearance on 1992-12-01 under 510(k) number K923768. The device is classified under product code DCK. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PULSE CRP TEST?

PULSE CRP TEST is a medical device that received FDA 510(k) clearance on 1992-12-01. The listed applicant is Pulse Scientific, Inc.. The 510(k) number is K923768.

When did PULSE CRP TEST receive FDA 510(k) clearance?

PULSE CRP TEST received FDA 510(k) clearance on 1992-12-01, under 510(k) number K923768.

Who is the listed applicant for PULSE CRP TEST?

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

What is the FDA product code for PULSE CRP TEST?

The FDA product code for PULSE CRP TEST is DCK.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Pulse Scientific, 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.

K923767PULSE IM RED CELL TESTK923771PULSE RF TEST

Related Devices (Code: DCK)

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.

K242170K-ASSAY CRP (Ver.2)Kamiya Biomedical Company, LLCK201256Procise CRP, ProciseDx Analyzer, ProciseDx Calibration CartridgeProcise DiagnosticsK192028Yumizen C1200 CRPHORIBA ABX SASK192118CRP VarioSENTINEL CH. SpAK191993Yumizen C1200 CRPHORIBA ABX SASK160712VITROS Chemistry Products hsCRP ReagentOrtho Clinical Diagnostics

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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