510(k) K020156
- Device
- DIASTAT TOTAL ANTI-CARDIOLIPIN, MODEL FCAR 100T
- Applicant
- Axis-Shield Diagnostics, Ltd.
- 510(k) number
- K020156
- Product code
- MID
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-03-06
- Date received
- 2002-01-17
- Regulation
- 866.5660
- Classification name
- System, Test, Anticardiolipin Immunological
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- N
Applicant Contact#
- Contact
- EILEEN MCCAFFERTY
- Address
- The Technology Park Luna Pl. Dundee, Scotland GB DD2 1XA DD2 1XA
FDA Registration Numbers#
- 3003825930
- 1421346
- 3032705
- 1721937
- 3039353646
- 3002800697
- 8043792
- 3004973408
- 2245285
- 9680745
- 3022178699
- 1217183
- 1832216
- 2915274
- 1529254
- 1181055
- 1222302
- 2026994
- 9610566
- 3012348571
- 9610746
- 2242436
- 3037000637
- 2029372
- 2918768
Source Documents#
510(k) summary PDF not indicated by FDA
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