ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229— 510(k) K974816
Substantially EquivalentBeckman Instruments, Inc.
FDA 510(k) clearance K974816 for ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229, Substantially Equivalent on 1998-02-20. Applicant: Beckman Instruments, Inc.. Device class: 2.
Clearance details
- Applicant
- Beckman Instruments, Inc.
- Product code
- Code LTJ
- Device class
- Class 2
- Regulation
- 21 CFR 866.6010
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chaska, MN, US
Recent devices under product code LTJ
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- K981354 — ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211
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Data sourced from openFDA. This site is unofficial and independent of the FDA.