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FDA 510(k)

QUANTA LITE MITOCHONDRIA M2 ELISA

K-Number: K933180 · 1993-08-05

ApplicantInova Diagnostics, Inc.
Decision Date1993-08-05
Product CodeDGC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

QUANTA LITE MITOCHONDRIA M2 ELISA 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 1993-08-05 under 510(k) number K933180. The device is classified under product code DGC. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUANTA LITE MITOCHONDRIA M2 ELISA?

QUANTA LITE MITOCHONDRIA M2 ELISA is a medical device that received FDA 510(k) clearance on 1993-08-05. The listed applicant is Inova Diagnostics, Inc.. The 510(k) number is K933180.

When did QUANTA LITE MITOCHONDRIA M2 ELISA receive FDA 510(k) clearance?

QUANTA LITE MITOCHONDRIA M2 ELISA received FDA 510(k) clearance on 1993-08-05, under 510(k) number K933180.

Who is the listed applicant for QUANTA LITE MITOCHONDRIA M2 ELISA?

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 LITE MITOCHONDRIA M2 ELISA?

The FDA product code for QUANTA LITE MITOCHONDRIA M2 ELISA is DGC.

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Related Devices (Code: DGC)

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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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