TOTAL BILIRUBIN REAGENT KIT FOR ASTRA SYSTEMS— 510(k) K884224
Substantially EquivalentA-Kem, Inc.
FDA 510(k) clearance K884224 for TOTAL BILIRUBIN REAGENT KIT FOR ASTRA SYSTEMS, Substantially Equivalent on 1988-12-15. Applicant: A-Kem, Inc..
Clearance details
- Applicant
- A-Kem, Inc.
- Product code
- Code CIG
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Clifton, NJ, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.