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FDA 510(k)

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

K-Number: K152635 · 2016-06-01

ApplicantInova Diagnostics, Inc.
Decision Date2016-06-01
Product CodeLLL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Inova Diagnostics, Inc.. The 510(k) number is K152635.

When was QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls approved by the FDA?

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

What company makes 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 manufactured by Inova Diagnostics, Inc..

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.

Other Devices by Inova Diagnostics, Inc.

K152013QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls K151429QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols K170993QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer K163538QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls K163525QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) Controls K161258NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit

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Related Devices (Code: LLL)

K151429QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 CiontrolsInova Diagnostics, Inc. K180975QUANTA Flash HMGCR ReagentsInova Diagnostics, Inc. K190710EliA SymphonyS ImmunoassayPhadia AB K213403Aptiva CTD Essential ReagentInova Diagnostics, Inc. K250666Alegria Flash CTD ScreenZeus Scientific K250408Alegria Flash ENA ScreenZeus Scientific

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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