HEPARIN ACA ANALYTICAL TEST PACK
FDA 510(k) clearance K843201 · decided 1984-11-30
Clearance details
- K-number
- K843201
- Device name
- HEPARIN ACA ANALYTICAL TEST PACK
- Applicant
- E.I. Dupont DE Nemours & Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-08-14
- Decision date
- 1984-11-30
- Days to decision
- 108 days
- Clearance type
- Traditional
- Product code
- KFF
- Device class
- 2
- Regulation number
- 864.7525
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- 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.