DATA REDUCTION SYSTEM, DP-3000— 510(k) K770877

Substantially Equivalent

Beckman Instruments, Inc.

FDA 510(k) clearance K770877 for DATA REDUCTION SYSTEM, DP-3000, Substantially Equivalent on 1977-07-21. Applicant: Beckman Instruments, Inc.. Device class: 1.

Clearance details

Applicant
Beckman Instruments, Inc.
Product code
Code JQP
Device class
Class 1
Regulation
21 CFR 862.2100
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
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Adverse events under product code JQP

product code JQP
Death
3
Malfunction
690
Total
693

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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