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FDA 510(k)

FORMULATION HWS-128 EPA REG. NO. 47371-130

K-Number: K953009 · 1995-08-11

ApplicantHuntington Laboratories, Inc.
Decision Date1995-08-11
Product CodeLRJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

FORMULATION HWS-128 EPA REG. NO. 47371-130 is the device name listed in this FDA 510(k) record. The listed applicant is Huntington Laboratories, Inc.. It received FDA 510(k) clearance on 1995-08-11 under 510(k) number K953009. 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 FORMULATION HWS-128 EPA REG. NO. 47371-130?

FORMULATION HWS-128 EPA REG. NO. 47371-130 is a medical device that received FDA 510(k) clearance on 1995-08-11. The listed applicant is Huntington Laboratories, Inc.. The 510(k) number is K953009.

When did FORMULATION HWS-128 EPA REG. NO. 47371-130 receive FDA 510(k) clearance?

FORMULATION HWS-128 EPA REG. NO. 47371-130 received FDA 510(k) clearance on 1995-08-11, under 510(k) number K953009.

Who is the listed applicant for FORMULATION HWS-128 EPA REG. NO. 47371-130?

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

What is the FDA product code for FORMULATION HWS-128 EPA REG. NO. 47371-130?

The FDA product code for FORMULATION HWS-128 EPA REG. NO. 47371-130 is LRJ. This falls under the Clinical Lab category.

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Other records listing Huntington Laboratories, 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.

K960580BEAUCOUP GENERAL PURPOSE DISINFECTANTK960583MATAR GENERAL PURPOSE DISINFECTANTK960582ASCEND GENERAL PURPOSE DISINFECTANTK953011FORMULATION HWS-64 EPA REG. NO. 47371-131K953010FORMULATION HWS-256 EPA REG. NO. 47371-129K853653SANA-LUBE

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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

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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