K760194
Substantially EquivalentNDC#12739-0010-1 C-ZYME GPT
- Applicant
- Coulter Electronics, Inc.
- Product code
- CKA
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.