DC-3 FLUIDS PACK, DC-5 FLUIDS PACK
FDA 510(k) clearance K852595 · decided 1985-07-12
Clearance details
- K-number
- K852595
- Device name
- DC-3 FLUIDS PACK, DC-5 FLUIDS PACK
- Applicant
- Diagnostic Chemicals, Ltd. (Usa)
- Decision
- Substantially Equivalent
- Date received
- 1985-06-19
- Decision date
- 1985-07-12
- Days to decision
- 23 days
- Clearance type
- Traditional
- Product code
- JGS
- Device class
- 2
- Regulation number
- 862.1665
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Charlottestown,Pei,Canada, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.