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FDA 510(k)

ABTOX PLAZLYTE PROCESS MONITOR

K-Number: K923442 · 1994-12-22

ApplicantAbtox, Inc.
Decision Date1994-12-22
Product CodeFLF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ABTOX PLAZLYTE PROCESS MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Abtox, Inc.. It received FDA 510(k) clearance on 1994-12-22 under 510(k) number K923442. The device is classified under product code FLF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABTOX PLAZLYTE PROCESS MONITOR?

ABTOX PLAZLYTE PROCESS MONITOR is a medical device that received FDA 510(k) clearance on 1994-12-22. The listed applicant is Abtox, Inc.. The 510(k) number is K923442.

When did ABTOX PLAZLYTE PROCESS MONITOR receive FDA 510(k) clearance?

ABTOX PLAZLYTE PROCESS MONITOR received FDA 510(k) clearance on 1994-12-22, under 510(k) number K923442.

Who is the listed applicant for ABTOX PLAZLYTE PROCESS MONITOR?

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

What is the FDA product code for ABTOX PLAZLYTE PROCESS MONITOR?

The FDA product code for ABTOX PLAZLYTE PROCESS MONITOR is FLF.

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Other records listing Abtox, 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.

K905119PLAZLYTE(TM)K923739ABTOX SERILIZATION PROCESS BIOLOGICAL INDICATOR

Related Devices (Code: FLF)

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.

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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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