510(k) K030238
- Device
- BINDAZYME ANTI-MITOCHONDRIA M2 IGGAM EIA KIT
- Applicant
- The Binding Site, Ltd.
- 510(k) number
- K030238
- Product code
- DBM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-03-24
- Date received
- 2003-01-23
- Regulation
- 866.5090
- Classification name
- Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- N
Applicant Contact#
- Contact
- JAY H GELLER
- Address
- West Tower, Suite 4000 2425 W. Olympic Blvd. Santa Monica CA US 90404 90404
FDA Registration Numbers#
- 8043792
- 2026994
- 3007361513
- 3003268355
- 3012348571
- 1318354
- 3032705
- 2242436
- 2029372
- 3004973408
- 9610566
- 1181055
- 3007118747
- 2915274
- 9616003
Source Documents#
510(k) summary PDF not indicated by FDA
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| K940251 | MITOCHONDRIA EIA TEST KIT | David A. Fuccillo, Ph.D. | 1994-05-03 |
| K930143 | AYNELISA M2-ANTIBODIES | Elias U.S.A., Inc. | 1993-05-11 |
| K921183 | DIASTAT ANTI-MITOCHONDRIAL ANTIBODY KIT | Shield Diagnostics, Ltd. | 1992-06-19 |
| K843181 | AUTOFLUOR IV SYSTEM | Tech America Diagnostics | 1984-09-17 |