FDA · official record K830837Substantially Equivalent

LA-HISTO ANTIBODY SYSTEM #HL 1001

Name: LA-HISTO ANTIBODY SYSTEM #HL 1001 — FDA K830837
Creator: Immuno-Mycologics, Inc.
Keywords: LA-HISTO ANTIBODY SYSTEM #HL 1001, LA-HISTO ANTIBODY SYSTEM #HL 1001, K830837, GMJ, FDA

United StatesGMJImmuno-Mycologics, Inc.

Verified

Official record identity

FDA application number: K830837
Decision date: May 05, 1983
Published decision: Substantially Equivalent

Classification

Product code: GMJ

Published parties

Applicant: Immuno-Mycologics, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1983-03-16
Review panel: Microbiology
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 866.3320

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.