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FDA 510(k)

QUANTA Flash HMGCR Reagents

K-Number: K180975 · 2018-06-25

ApplicantInova Diagnostics, Inc.
Decision Date2018-06-25
Product CodeLLL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

QUANTA Flash HMGCR Reagents is a medical device manufactured by Inova Diagnostics, Inc.. It received FDA 510(k) clearance on 2018-06-25 under approval number K180975. 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 HMGCR Reagents?

QUANTA Flash HMGCR Reagents is a medical device that received FDA 510(k) clearance on 2018-06-25. It is manufactured by Inova Diagnostics, Inc.. The 510(k) number is K180975.

When was QUANTA Flash HMGCR Reagents approved by the FDA?

QUANTA Flash HMGCR Reagents received FDA 510(k) clearance on 2018-06-25, under approval number K180975.

What company makes QUANTA Flash HMGCR Reagents?

QUANTA Flash HMGCR Reagents is manufactured by Inova Diagnostics, Inc..

What is the FDA product code for QUANTA Flash HMGCR Reagents?

The FDA product code for QUANTA Flash HMGCR Reagents is LLL.

Other Devices by Inova Diagnostics, Inc.

K152635QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls 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

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Related Devices (Code: LLL)

K152635QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 ControlsInova Diagnostics, Inc. K151429QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 CiontrolsInova 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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