ANALYST THEOPHYLLINE ROTOR
FDA 510(k) clearance K884002 · decided 1988-10-31
Clearance details
- K-number
- K884002
- Device name
- ANALYST THEOPHYLLINE ROTOR
- Applicant
- The DU Pont Co.
- Decision
- Substantially Equivalent
- Date received
- 1988-09-21
- Decision date
- 1988-10-31
- Days to decision
- 40 days
- Clearance type
- Traditional
- Product code
- KLS
- Device class
- 2
- Regulation number
- 862.3880
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Wilmington, DE, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.