ANALYST ANALYTICAL TEST ROTORS
FDA 510(k) clearance K862274 · decided 1986-07-29
Clearance details
- K-number
- K862274
- Device name
- ANALYST ANALYTICAL TEST ROTORS
- Applicant
- E.I. Dupont DE Nemours & Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-06-16
- Decision date
- 1986-07-29
- Days to decision
- 43 days
- Clearance type
- Traditional
- Product code
- CIC
- Device class
- 2
- Regulation number
- 862.1145
- 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.