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FDA 510(k)

PRO-PORTION CLEANER/DISINFECTANT

K-Number: K991509 · 1999-07-14

ApplicantSultan Chemists, Inc.
Decision Date1999-07-14
Product CodeLRJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PRO-PORTION CLEANER/DISINFECTANT is the device name listed in this FDA 510(k) record. The listed applicant is Sultan Chemists, Inc.. It received FDA 510(k) clearance on 1999-07-14 under 510(k) number K991509. 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-PORTION CLEANER/DISINFECTANT?

PRO-PORTION CLEANER/DISINFECTANT is a medical device that received FDA 510(k) clearance on 1999-07-14. The listed applicant is Sultan Chemists, Inc.. The 510(k) number is K991509.

When did PRO-PORTION CLEANER/DISINFECTANT receive FDA 510(k) clearance?

PRO-PORTION CLEANER/DISINFECTANT received FDA 510(k) clearance on 1999-07-14, under 510(k) number K991509.

Who is the listed applicant for PRO-PORTION CLEANER/DISINFECTANT?

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

What is the FDA product code for PRO-PORTION CLEANER/DISINFECTANT?

The FDA product code for PRO-PORTION CLEANER/DISINFECTANT is LRJ. This falls under the Clinical Lab category.

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Other records listing Sultan Chemists, 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.

K052699VERSA-LINK PORCELAIN BONDING SYSTEMK052409SILGIMIX ALGINATE REPLACEMENT IMPRESSION MATERIALK043054GENIE MAGIC MIX ULTRA HYDROPHILIC IMPRESSION MATERIALK030414GENIE ULTRA HYDROPHILIC IMPRESSION MATERIALK020612SULTAN SPOROX TEST VIAL, MODEL 75195K002843SULTAN SENSITEMP RESIN TEMPORARY CEMENT, MODEL 70010

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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.K984485MICROSTAT 2Chemlink Laboratories, LLCK983947AMERSE 2STERIS CorporationK983869DISPATCH HOSPITAL CLEANER DISINFECTANT TOWELS WITH BLEACHCaltech Industries, Inc.K983585LOW PH PHENOLIC 256Central Solutions, Inc.K982985CITREX HOSPITAL SPRAY DISINFECTANTCaltech Industries, 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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