FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ON CALL MULTI-DRUG HOME TEST CUP
K Number: K050878
·
Decision Jun 8, 2005
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
149
Applicant Total
85
Review Days
63
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
- ON CALL MULTI-DRUG HOME TEST CUP
- K Number
- K050878
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3870
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ACON Laboratories, Inc.
- Date Received
- April 6, 2005
- Decision Date
- June 8, 2005
- Product Code
- LDJ
- Advisory Committee
- Clinical Toxicology
- 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 |
|---|---|---|---|
| LDJ | Enzyme Immunoassay, Cannabinoids | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LDJ), ordered by most recent decision date.
Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid Marijuana (THC) Test Dipcard 50
FDA 510(k)
FDA Class 2
·Clinical Toxicology
LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit (Cassette)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT
FDA 510(k)
FDA Class 2
·Clinical Toxicology
BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20
FDA 510(k)
FDA Class 2
·Clinical Toxicology
CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test
FDA 510(k)
FDA Class 2
·Clinical Toxicology
EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine Test Cassette Marijuana
FDA 510(k)
FDA Class 2
·Clinical Toxicology
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 |