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FDA 510(k)

PRO-TECH

K-Number: K955850 · 1996-02-09

Decision Date1996-02-09
Product CodeLRJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PRO-TECH is the device name listed in this FDA 510(k) record. The listed applicant is Central Solutions, Inc.. It received FDA 510(k) clearance on 1996-02-09 under 510(k) number K955850. The device is classified under product code LRJ. It was reviewed by the HO advisory panel. Product code LRJ falls under the category of Clinical Lab, which includes general clinical laboratory instruments. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRO-TECH?

PRO-TECH is a medical device that received FDA 510(k) clearance on 1996-02-09. The listed applicant is Central Solutions, Inc.. The 510(k) number is K955850.

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

PRO-TECH received FDA 510(k) clearance on 1996-02-09, under 510(k) number K955850.

Who is the listed applicant for PRO-TECH?

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

What is the FDA product code for PRO-TECH?

The FDA product code for PRO-TECH is LRJ. This falls under the Clinical Lab category.

Other records listing Central 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.

View all 7 devices →

Related Devices (Code: LRJ)

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.

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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