BIOCENTREX CARDIAC PANEL
FDA 510(k) clearance K033155 · decided 2004-01-12
Clearance details
- K-number
- K033155
- Device name
- BIOCENTREX CARDIAC PANEL
- Applicant
- Biocentrex
- Decision
- Substantially Equivalent
- Date received
- 2003-09-30
- Decision date
- 2004-01-12
- Days to decision
- 104 days
- Clearance type
- Traditional
- Product code
- MYT
- Device class
- 2
- Regulation number
- 862.1215
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Culver City, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| I-STAT CREATINE KINASE MB (CK-MB) (K051433) | I-Stat Corporation | 2005-12-15 |
| QUANTECH CK-MB ASSAY (K984433) | Quantech , Ltd. | 1999-11-01 |
Recalls involving this device
No recalls on record reference this clearance.