FDA · official record K091753Substantially Equivalent

ELVIS HSV ID AND D3 TYPING TEST SYSTEM

Name: ELVIS HSV ID AND D3 TYPING TEST SYSTEM — FDA K091753
Creator: Diagnostic Hybrids, Inc.
Keywords: ELVIS HSV ID AND D3 TYPING TEST SYSTEM, ELVIS HSV ID AND D3 TYPING TEST SYSTEM, K091753, GQL, FDA

United StatesGQLDiagnostic Hybrids, Inc.

Verified

Official record identity

FDA application number: K091753
Decision date: August 28, 2009
Published decision: Substantially Equivalent

Classification

Product code: GQL

Published parties

Applicant: Diagnostic Hybrids, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2009-06-16
Review panel: Microbiology
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 866.3305

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.