510(k) K051433
- Device
- I-STAT CREATINE KINASE MB (CK-MB)
- Applicant
- I-STAT CORPORATION
- 510(k) number
- K051433
- Product code
- MYT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-12-15
- Date received
- 2005-06-01
- Regulation
- 862.1215
- Classification name
- Biosensor, Immunoassay, Cpk Or Isoenzymes
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- SUE KENT
- Address
- 104 Windsor Center Dr. East Windsor NJ US 08520 08520
FDA Registration Numbers#
- 3006198300
- 2245578
- 3005643513
Source Documents#
Other 510(k) Records For Product Code MYT #
Legacy Summary#
summary
FDA Review#
Decision Summary