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FDA 510(k)

OPIATES MICRO-PLATE ASSAY

K-Number: K935565 · 1995-07-14

ApplicantSolarcare Technologies Corp,Inc.
Decision Date1995-07-14
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

OPIATES MICRO-PLATE ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Solarcare Technologies Corp,Inc.. It received FDA 510(k) clearance on 1995-07-14 under 510(k) number K935565. The device is classified under product code DJG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPIATES MICRO-PLATE ASSAY?

OPIATES MICRO-PLATE ASSAY is a medical device that received FDA 510(k) clearance on 1995-07-14. The listed applicant is Solarcare Technologies Corp,Inc.. The 510(k) number is K935565.

When did OPIATES MICRO-PLATE ASSAY receive FDA 510(k) clearance?

OPIATES MICRO-PLATE ASSAY received FDA 510(k) clearance on 1995-07-14, under 510(k) number K935565.

Who is the listed applicant for OPIATES MICRO-PLATE ASSAY?

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

What is the FDA product code for OPIATES MICRO-PLATE ASSAY?

The FDA product code for OPIATES MICRO-PLATE ASSAY is DJG.

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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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