FDA 510(k)

QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls

K-Nummer: K152635 · 2016-06-01

Entscheidungsdatum2016-06-01

ProduktcodeLLL

BeratungsausschussIM

EntscheidungSubstantially Equivalent

Produktübersicht

QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls is the device name listed in this FDA 510(k) record. The listed applicant is Inova Diagnostics, Inc.. It received FDA 510(k) clearance on 2016-06-01 under 510(k) number K152635. The device is classified under product code LLL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls?

QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls is a medical device that received FDA 510(k) clearance on 2016-06-01. The listed applicant is Inova Diagnostics, Inc.. The 510(k) number is K152635.

When did QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls receive FDA 510(k) clearance?

QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls received FDA 510(k) clearance on 2016-06-01, under 510(k) number K152635.

Who is the listed applicant for QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls?

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

What is the FDA product code for QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls?

The FDA product code for QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls is LLL.

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Offizielle Quelle

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