UC IMU A
FDA 510(k) clearance K904125 · decided 1990-09-24
Clearance details
- K-number
- K904125
- Device name
- UC IMU A
- Applicant
- Eucardio Laboratory, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-09-06
- Decision date
- 1990-09-24
- Days to decision
- 18 days
- Clearance type
- Traditional
- Product code
- DER
- Device class
- 2
- Regulation number
- 866.5580
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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| APOLIPOPROTEIN A1 (K983289) | Abbott Laboratories | 1999-01-29 |
| N-ASSAY TIA APO A1/B MULTI CALIBRATOR (K964294) | Crestat Diagnostics, Inc. | 1997-08-01 |
| N-ASSAY TIA APO B TEST KIT (K964296) | Crestat Diagnostics, Inc. | 1997-08-01 |
| N-ASSAY TIA APO A1 TEST KIT (K964292) | Crestat Diagnostics, Inc. | 1997-08-01 |
| ROCHE APOLIPOPROTEIN STANDARD (K910553) | Roche Diagnostic Systems, Inc. | 1991-05-08 |
| QC3 WHOLE HUMAN SERUM, HDL-CHOLESTEROL CONTROL (K872078) | Solomon Park Research Laboratories | 1987-06-18 |
| APO-SCREEN CALIBRATOR & CONTROL SET FOR HDL APO A1 (K854875) | Photec Diagnostics, Inc. | 1986-01-24 |
Recalls involving this device
No recalls on record reference this clearance.