EMIT D.A.U. LOW & MEDIUM CALIBRATOR A
FDA 510(k) clearance K894327 · decided 1989-08-03
Clearance details
- K-number
- K894327
- Device name
- EMIT D.A.U. LOW & MEDIUM CALIBRATOR A
- Applicant
- Syva Co.
- Decision
- Substantially Equivalent
- Date received
- 1989-07-14
- Decision date
- 1989-08-03
- Days to decision
- 20 days
- Clearance type
- Traditional
- Product code
- DKG
- Device class
- 1
- Regulation number
- 862.2270
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Palo Alto, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.