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FDA 510(k)

AMERSE

K-Number: K931477 · 1994-06-17

ApplicantCalgon Vestal Div.
Decision Date1994-06-17
Product CodeLRJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AMERSE is the device name listed in this FDA 510(k) record. The listed applicant is Calgon Vestal Div.. It received FDA 510(k) clearance on 1994-06-17 under 510(k) number K931477. 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 AMERSE?

AMERSE is a medical device that received FDA 510(k) clearance on 1994-06-17. The listed applicant is Calgon Vestal Div.. The 510(k) number is K931477.

When did AMERSE receive FDA 510(k) clearance?

AMERSE received FDA 510(k) clearance on 1994-06-17, under 510(k) number K931477.

Who is the listed applicant for AMERSE?

The FDA 510(k) record lists Calgon Vestal Div. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMERSE?

The FDA product code for AMERSE is LRJ. This falls under the Clinical Lab category.

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Other records listing Calgon Vestal Div. 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.

K944494ALSA-KLENZK944033BILL EVANS-KLENZK942270SAF-GEL HYDRATING DERMAL WOUND DRESSINGK931342LPHK931816VESTA-SYDE(R) INTERIM INSTR DECONTAMINATION SYSTEMK941163MON-KLENZ

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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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