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FDA 510(k)

ASTRA 300

K-Number: K061571 · 2007-01-31

ApplicantSdi Diagnostics, Inc.
Decision Date2007-01-31
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ASTRA 300 is the device name listed in this FDA 510(k) record. The listed applicant is Sdi Diagnostics, Inc.. It received FDA 510(k) clearance on 2007-01-31 under 510(k) number K061571. The device is classified under product code BZG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASTRA 300?

ASTRA 300 is a medical device that received FDA 510(k) clearance on 2007-01-31. The listed applicant is Sdi Diagnostics, Inc.. The 510(k) number is K061571.

When did ASTRA 300 receive FDA 510(k) clearance?

ASTRA 300 received FDA 510(k) clearance on 2007-01-31, under 510(k) number K061571.

Who is the listed applicant for ASTRA 300?

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

What is the FDA product code for ASTRA 300?

The FDA product code for ASTRA 300 is BZG.

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Other records listing Sdi Diagnostics, Inc. as applicant

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Related Devices (Code: BZG)

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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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