EPSILON HCG TEST KIT MONOCLONAL— 510(k) K842654
Substantially EquivalentBeckman Instruments, Inc.
FDA 510(k) clearance K842654 for EPSILON HCG TEST KIT MONOCLONAL, Substantially Equivalent on 1984-10-01. Applicant: Beckman Instruments, Inc.. Device class: 2.
Clearance details
- Applicant
- Beckman Instruments, Inc.
- Product code
- Product code JHI
- Device class
- Class 2
- Regulation
- 21 CFR 862.1155
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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- K980173 — ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505
Adverse events under product code JHI
product code JHI- Malfunction
- 1,055
- Total
- 1,055
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.