510(k) K011068
- Device
- RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L
- Applicant
- Rhigene, Inc.
- 510(k) number
- K011068
- Product code
- KTL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-04-11
- Date received
- 2001-04-09
- Regulation
- 866.5100
- Classification name
- Anti-Dna Indirect Immunofluorescent Solid Phase
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- N
Applicant Contact#
- Contact
- DAVID KOLESAR
- Address
- 455 State St., Suite 104 Des Plaines IL US 60068 60068
FDA Registration Numbers#
- 3026753391
- 2915274
- 3007118747
- 2918768
- 3003268355
- 2242436
- 3007361513
- 2026994
Source Documents#
510(k) summary PDF not indicated by FDA
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