FDA 510(k)

MICROSCAN MICROSTREP PLUS, MODEL B1027-201

K-Number: K091949 · 2010-01-26

Decision Date2010-01-26

Product CodeLTT

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

MICROSCAN MICROSTREP PLUS, MODEL B1027-201 is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics. It received FDA 510(k) clearance on 2010-01-26 under 510(k) number K091949. The device is classified under product code LTT. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROSCAN MICROSTREP PLUS, MODEL B1027-201?

MICROSCAN MICROSTREP PLUS, MODEL B1027-201 is a medical device that received FDA 510(k) clearance on 2010-01-26. The listed applicant is Siemens Healthcare Diagnostics. The 510(k) number is K091949.

When did MICROSCAN MICROSTREP PLUS, MODEL B1027-201 receive FDA 510(k) clearance?

MICROSCAN MICROSTREP PLUS, MODEL B1027-201 received FDA 510(k) clearance on 2010-01-26, under 510(k) number K091949.

Who is the listed applicant for MICROSCAN MICROSTREP PLUS, MODEL B1027-201?

The FDA 510(k) record lists Siemens Healthcare Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MICROSCAN MICROSTREP PLUS, MODEL B1027-201?

The FDA product code for MICROSCAN MICROSTREP PLUS, MODEL B1027-201 is LTT.

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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.