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FDA 510(k)

APPLIED BIOSYSTEMS 7500 FAST DX

K-Number: K082562 · 2008-09-30

ApplicantApplied Biosystems, Inc.
Decision Date2008-09-30
Product CodeNSU
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

APPLIED BIOSYSTEMS 7500 FAST DX is the device name listed in this FDA 510(k) record. The listed applicant is Applied Biosystems, Inc.. It received FDA 510(k) clearance on 2008-09-30 under 510(k) number K082562. The device is classified under product code NSU. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the APPLIED BIOSYSTEMS 7500 FAST DX?

APPLIED BIOSYSTEMS 7500 FAST DX is a medical device that received FDA 510(k) clearance on 2008-09-30. The listed applicant is Applied Biosystems, Inc.. The 510(k) number is K082562.

When did APPLIED BIOSYSTEMS 7500 FAST DX receive FDA 510(k) clearance?

APPLIED BIOSYSTEMS 7500 FAST DX received FDA 510(k) clearance on 2008-09-30, under 510(k) number K082562.

Who is the listed applicant for APPLIED BIOSYSTEMS 7500 FAST DX?

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

What is the FDA product code for APPLIED BIOSYSTEMS 7500 FAST DX?

The FDA product code for APPLIED BIOSYSTEMS 7500 FAST DX is NSU.

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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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