DU PONT ANALYST ANALYTICAL TEST ROTOR:CHEM-14,CALI
FDA 510(k) clearance K901017 · decided 1990-05-15
Clearance details
- K-number
- K901017
- Device name
- DU PONT ANALYST ANALYTICAL TEST ROTOR:CHEM-14,CALI
- Applicant
- E.I. Dupont DE Nemours & Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-03-05
- Decision date
- 1990-05-15
- Days to decision
- 71 days
- Clearance type
- Traditional
- Product code
- JFJ
- Device class
- 2
- Regulation number
- 862.1070
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- 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.