QCLYTE PROTEIN-BASED ISE CONTROL— 510(k) K895582
Substantially EquivalentBaxter Healthcare Corp
FDA 510(k) clearance K895582 for QCLYTE PROTEIN-BASED ISE CONTROL, Substantially Equivalent on 1989-10-04. Applicant: Baxter Healthcare Corp. Device class: 1.
Clearance details
- Applicant
- Baxter Healthcare Corp
- Product code
- Code JJR
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Ana, CA, US
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