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510(k) K962399

Device
HEPATITIS NEGATIVE CONTROL
Applicant
PYRAMID BIOLOGICAL CORP.
510(k) number
K962399
Product code
MJY  
Decision
Substantially Equivalent (SESE)
Decision date
1996-08-02
Date received
1996-06-21
Regulation
862.1660
Classification name
Kit, Serological, Negative Control
Medical specialty
Clinical Chemistry
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
JEANETTE R PORRETTA
Address
6454 Van Nuys Blvd., Suite 111 Van Nuys CA US 91401 91401

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Legacy Summary#

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FDA Review#

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