FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FORESIGHT U120 URINE ANALYZER
K Number: K120124
·
Decision Mar 6, 2012
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
80
Applicant Total
85
Review Days
49
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- FORESIGHT U120 URINE ANALYZER
- K Number
- K120124
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 862.1340
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- ACON Laboratories, Inc.
- Date Received
- January 17, 2012
- Decision Date
- March 6, 2012
- Product Code
- JIL
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JIL | Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JIL), ordered by most recent decision date.
AUTION MAX AX-4060 Urinalysis System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
cobas u 601 urinalysis test system
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DIP/U.S. Urine Analysis Test System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
inui In-Home Urine Analysis Test System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DUS R-50S (Urine Chemistry system)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by ACON Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K251697 | Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip | Nov 26, 2025 | Substantially Equivalent |
| K251749 | Flowflex Plus RSV + Flu A/B + COVID Home Test | Oct 22, 2025 | Substantially Equivalent |
| K250085 | On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System | Oct 10, 2025 | Substantially Equivalent |
| K250377 | Flowflex Plus COVID-19 + Flu A/B Home Test | May 10, 2025 | Substantially Equivalent |
| K232715 | Distinct® Digital Pregnancy Test | May 31, 2024 | Substantially Equivalent |
| K233373 | Flowflex® Plus COVID-19 Home Test | Apr 19, 2024 | Substantially Equivalent |
| K230828 | Flowflex COVID-19 Antigen Home Test | Nov 9, 2023 | Substantially Equivalent |
| K193318 | Distinct® Early Detection Pregnancy Test | Aug 20, 2020 | Substantially Equivalent |
| K192175 | On Call Express II Blood Glucose Monitoring System | Oct 17, 2019 | Substantially Equivalent |
| K191038 | On Call Express Voice Blood Glucose Monitoring System | Jun 12, 2019 | Substantially Equivalent |