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FDA 510(k)

PARA-PRO FC50

K-Number: K053257 · 2006-05-12

ApplicantAlpha-Tec Systems, Inc.
Decision Date2006-05-12
Product CodeLKS
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PARA-PRO FC50 is the device name listed in this FDA 510(k) record. The listed applicant is Alpha-Tec Systems, Inc.. It received FDA 510(k) clearance on 2006-05-12 under 510(k) number K053257. 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 PARA-PRO FC50?

PARA-PRO FC50 is a medical device that received FDA 510(k) clearance on 2006-05-12. The listed applicant is Alpha-Tec Systems, Inc.. The 510(k) number is K053257.

When did PARA-PRO FC50 receive FDA 510(k) clearance?

PARA-PRO FC50 received FDA 510(k) clearance on 2006-05-12, under 510(k) number K053257.

Who is the listed applicant for PARA-PRO FC50?

The FDA 510(k) record lists Alpha-Tec Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PARA-PRO FC50?

The FDA product code for PARA-PRO FC50 is LKS.

Other records listing Alpha-Tec Systems, Inc. as applicant

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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.

K021420PARACON II/FECAL CONCENTRATOR IIPara Scientific Co.K980077PARA-PAK SPINCONMeridian Diagnostics, Inc.K941110PARAKITHardy DiagnosticsK941129CON-KITMedical Chemical Corp.K933370STOOL TRANSPORT/PROCESSORSage Products, Inc.K935316PARASAFE(R) FIXATIVEScientific Device Laboratory, 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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