510(k) K930796
- Device
- ISE CALIBRATORS FOR CORNING 600 SERIES ANALYZERS
- Applicant
- ALKO DIAGNOSTIC CORP.
- 510(k) number
- K930796
- Product code
- JZX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-01-13
- Date received
- 1993-02-16
- Regulation
- 866.4830
- Classification name
- Equipment, Rocket Immunoelectrophoresis
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- BRIAN J YOUNG
- Address
- Alko Park 333 Fiske St. Holliston MA US 01746 01746
Source Documents#
Legacy Summary#
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FDA Review#
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