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FDA 510(k)

PARAPREP

K-Number: K931849 · 1993-12-02

ApplicantMedastat Scientific Corp.
Decision Date1993-12-02
Product CodeLKS
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PARAPREP is the device name listed in this FDA 510(k) record. The listed applicant is Medastat Scientific Corp.. It received FDA 510(k) clearance on 1993-12-02 under 510(k) number K931849. The device is classified under product code LKS. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PARAPREP?

PARAPREP is a medical device that received FDA 510(k) clearance on 1993-12-02. The listed applicant is Medastat Scientific Corp.. The 510(k) number is K931849.

When did PARAPREP receive FDA 510(k) clearance?

PARAPREP received FDA 510(k) clearance on 1993-12-02, under 510(k) number K931849.

Who is the listed applicant for PARAPREP?

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

What is the FDA product code for PARAPREP?

The FDA product code for PARAPREP is LKS.

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 Medastat Scientific Corp. 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.

K831408DNA FLORK822604ACID FAST QUALITY CONTROL SLIDES

Related Devices (Code: LKS)

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.

K053257PARA-PRO FC50Alpha-Tec Systems, Inc.K021420PARACON II/FECAL CONCENTRATOR IIPara Scientific Co.K980077PARA-PAK SPINCONMeridian Diagnostics, Inc.K941110PARAKITHardy DiagnosticsK941129CON-KITMedical Chemical Corp.K933370STOOL TRANSPORT/PROCESSORSage Products, Inc.

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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