DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KIT
FDA 510(k) clearance K963525 · decided 1996-11-07
Clearance details
- K-number
- K963525
- Device name
- DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KIT
- Applicant
- Shield Diagnostics, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1996-09-04
- Decision date
- 1996-11-07
- Days to decision
- 64 days
- Clearance type
- Traditional
- Product code
- DBL
- Device class
- 2
- Regulation number
- 866.5660
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Dundee, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.