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FDA 510(k)

MTM BIOSCANNER C TEST STRIPS MODEL NUMBER BSA 200, BSA 210, BSA 220

K-Number: K981493 · 1998-07-22

ApplicantPolymer Technology Systems, Inc.
Decision Date1998-07-22
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MTM BIOSCANNER C TEST STRIPS MODEL NUMBER BSA 200, BSA 210, BSA 220 is the device name listed in this FDA 510(k) record. The listed applicant is Polymer Technology Systems, Inc.. It received FDA 510(k) clearance on 1998-07-22 under 510(k) number K981493. The device is classified under product code CHH. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MTM BIOSCANNER C TEST STRIPS MODEL NUMBER BSA 200, BSA 210, BSA 220?

MTM BIOSCANNER C TEST STRIPS MODEL NUMBER BSA 200, BSA 210, BSA 220 is a medical device that received FDA 510(k) clearance on 1998-07-22. The listed applicant is Polymer Technology Systems, Inc.. The 510(k) number is K981493.

When did MTM BIOSCANNER C TEST STRIPS MODEL NUMBER BSA 200, BSA 210, BSA 220 receive FDA 510(k) clearance?

MTM BIOSCANNER C TEST STRIPS MODEL NUMBER BSA 200, BSA 210, BSA 220 received FDA 510(k) clearance on 1998-07-22, under 510(k) number K981493.

Who is the listed applicant for MTM BIOSCANNER C TEST STRIPS MODEL NUMBER BSA 200, BSA 210, BSA 220?

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

What is the FDA product code for MTM BIOSCANNER C TEST STRIPS MODEL NUMBER BSA 200, BSA 210, BSA 220?

The FDA product code for MTM BIOSCANNER C TEST STRIPS MODEL NUMBER BSA 200, BSA 210, BSA 220 is CHH.

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Related Devices (Code: CHH)

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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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