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FDA 510(k)

VARIANT TOTAL GHB PROGRAM

K-Number: K941616 · 1995-04-14

ApplicantBio-Rad
Decision Date1995-04-14
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

VARIANT TOTAL GHB PROGRAM is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1995-04-14 under 510(k) number K941616. The device is classified under product code LCP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VARIANT TOTAL GHB PROGRAM?

VARIANT TOTAL GHB PROGRAM is a medical device that received FDA 510(k) clearance on 1995-04-14. The listed applicant is Bio-Rad. The 510(k) number is K941616.

When did VARIANT TOTAL GHB PROGRAM receive FDA 510(k) clearance?

VARIANT TOTAL GHB PROGRAM received FDA 510(k) clearance on 1995-04-14, under 510(k) number K941616.

Who is the listed applicant for VARIANT TOTAL GHB PROGRAM?

The FDA 510(k) record lists Bio-Rad as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VARIANT TOTAL GHB PROGRAM?

The FDA product code for VARIANT TOTAL GHB PROGRAM is LCP.

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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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