STRATUS(R) AUTOMATED SAMPLE HANDLER— 510(k) K911712
Substantially EquivalentBaxter Healthcare Corp
FDA 510(k) clearance K911712 for STRATUS(R) AUTOMATED SAMPLE HANDLER, Substantially Equivalent on 1991-05-15. Applicant: Baxter Healthcare Corp. Device class: 1.
Clearance details
- Applicant
- Baxter Healthcare Corp
- Product code
- Code JQW
- Device class
- Class 1
- Regulation
- 21 CFR 862.2750
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Miami, FL, US
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