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FDA 510(k)

REAL-TIME PCR INTERNAL CONTROL 2B SET

K-Number: K083430 · 2009-01-15

ApplicantNanogen, Inc.
Decision Date2009-01-15
Product CodeOLD
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

REAL-TIME PCR INTERNAL CONTROL 2B SET is the device name listed in this FDA 510(k) record. The listed applicant is Nanogen, Inc.. It received FDA 510(k) clearance on 2009-01-15 under 510(k) number K083430. The device is classified under product code OLD. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REAL-TIME PCR INTERNAL CONTROL 2B SET?

REAL-TIME PCR INTERNAL CONTROL 2B SET is a medical device that received FDA 510(k) clearance on 2009-01-15. The listed applicant is Nanogen, Inc.. The 510(k) number is K083430.

When did REAL-TIME PCR INTERNAL CONTROL 2B SET receive FDA 510(k) clearance?

REAL-TIME PCR INTERNAL CONTROL 2B SET received FDA 510(k) clearance on 2009-01-15, under 510(k) number K083430.

Who is the listed applicant for REAL-TIME PCR INTERNAL CONTROL 2B SET?

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

What is the FDA product code for REAL-TIME PCR INTERNAL CONTROL 2B SET?

The FDA product code for REAL-TIME PCR INTERNAL CONTROL 2B SET is OLD.

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Other records listing Nanogen, Inc. as applicant

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Official Source

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