Official Classification
In accordance with Interscan’s 513(g) request for classification, the device is exempt from the premarket notification requirements of the Federal Food, Drug, and Cosmetic Act.
The Halimeter® is classified as follows:
Common/Generic Device Name: LABORATORY EQUIPMENT
Classification Name: EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE
Device Class: I
Product Code: LXG
Regulation Number: 862.2050
Medical Specialty: Clinical Chemistry
Registration Of Device Establishment
In accordance with Form FDA 2891, as issued by the US Department of Health and Human Services/Public Health Service/Food and Drug Administration – Center for Devices and Radiological Health, Rockville, MD, as issued to Interscan Corporation, Chatsworth, CA…
Owner/Operator Number: 9051481
Registered Establishment Name: INTERSCAN CORP.
Establishment Registration Number: 2032709
Date of Listing: 04/29/02
Listing Status: Active
Establishment Operations: Manufacturer
Foreign Customers and Dealers PLEASE NOTE
Notarized and officially sealed “Certificate To Foreign Government” documents, attesting that the Halimeter® may be marketed in, and legally exported from the United States, are available upon request. Normally, this document is only required the first time an instrument is exported to the country in question.
For further information on FDA matters, or other regulatory issues, please contact us.
