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MTM BIOSCANNER HDL - # Bsa450

FDA 510(k)

Class I (US FDA 510(k))

510(k) K990247

by Polymer Technology Systems

Identifiers

510(k) Number: K990247 FDA 510(k)
FDA Product Code: LBR FDA 510(k)
Models / Variants: # Bsa450 FDA 510(k)
Bsa460 FDA 510(k)
Bsa470 FDA 510(k)

Classification

Device Class: Class I FDA 510(k)
Legislation / Framework: 21 CFR Part 862.1475 FDA 510(k)
Regulation Number: 862.1475 FDA 510(k)
Advisory Committee: Clinical Chemistry FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

MTM BIOSCANNER HDL - # Bsa450 by Polymer Technology Systems — Class I — FDA_510K — listed in FDA 510(k) — 3 models — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer: Polymer Technology Systems
FDA Applicant: Polymer Technology Systems, Inc.

Sources (1)

FDA 510(k) K990247 24 fields · synced Jun 18, 2026