RDI LIPIDIRECT MAGNETIC LDL REAGENT
FDA 510(k) clearance K964064 · decided 1996-11-20
Clearance details
- K-number
- K964064
- Device name
- RDI LIPIDIRECT MAGNETIC LDL REAGENT
- Applicant
- Reference Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-10-10
- Decision date
- 1996-11-20
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- MRR
- Device class
- 1
- Regulation number
- 862.1475
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Bedford, MA, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.