ACA (R) DIGITOXIN CALIBRATOR
FDA 510(k) clearance K891093 · decided 1989-04-26
Clearance details
- K-number
- K891093
- Device name
- ACA (R) DIGITOXIN CALIBRATOR
- Applicant
- E.I. Dupont DE Nemours & Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-03-02
- Decision date
- 1989-04-26
- Days to decision
- 55 days
- Clearance type
- Traditional
- Product code
- DCJ
- Device class
- 1
- Regulation number
- 866.5160
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- 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.