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FDA 510(k)

NOVIGUARD QUICK DRY

K-Number: K961044 · 1997-07-03

ApplicantDr. Novis Smith & Co., Inc.
Decision Date1997-07-03
Product CodeLRJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NOVIGUARD QUICK DRY is the device name listed in this FDA 510(k) record. The listed applicant is Dr. Novis Smith & Co., Inc.. It received FDA 510(k) clearance on 1997-07-03 under 510(k) number K961044. 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 NOVIGUARD QUICK DRY?

NOVIGUARD QUICK DRY is a medical device that received FDA 510(k) clearance on 1997-07-03. The listed applicant is Dr. Novis Smith & Co., Inc.. The 510(k) number is K961044.

When did NOVIGUARD QUICK DRY receive FDA 510(k) clearance?

NOVIGUARD QUICK DRY received FDA 510(k) clearance on 1997-07-03, under 510(k) number K961044.

Who is the listed applicant for NOVIGUARD QUICK DRY?

The FDA 510(k) record lists Dr. Novis Smith & Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NOVIGUARD QUICK DRY?

The FDA product code for NOVIGUARD QUICK DRY is LRJ. This falls under the Clinical Lab category.

Related Clinical Trials

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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.

K992661CONTROL III ELITEMaril Products, Inc.K991509PRO-PORTION CLEANER/DISINFECTANTSultan Chemists, Inc.K984485MICROSTAT 2Chemlink Laboratories, LLCK983947AMERSE 2STERIS CorporationK983869DISPATCH HOSPITAL CLEANER DISINFECTANT TOWELS WITH BLEACHCaltech Industries, Inc.K983585LOW PH PHENOLIC 256Central Solutions, 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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