DADE(R) CK-MB/MYOGLOBIN IMMUN CONTROL, I,II,III
FDA 510(k) clearance K926046 · decided 1993-01-05
Clearance details
- K-number
- K926046
- Device name
- DADE(R) CK-MB/MYOGLOBIN IMMUN CONTROL, I,II,III
- Applicant
- Baxter Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-12-01
- Decision date
- 1993-01-05
- Days to decision
- 35 days
- Clearance type
- Traditional
- Product code
- JJY
- Device class
- 1
- Regulation number
- 862.1660
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Miami, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.