FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I
K Number: K002375
·
Decision Jan 26, 2001
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
149
Applicant Total
30
Review Days
175
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
- STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I
- K Number
- K002375
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3870
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- OraSure Technologies, Inc.
- Date Received
- August 4, 2000
- Decision Date
- January 26, 2001
- Product Code
- LDJ
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- TX
- 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 OraSure Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| DEN190025 | OraQuick Ebola Rapid Antigen Test | Oct 10, 2019 | Unknown |
| K060859 | COMPOUND W FREEZE OFF WART REMOVAL SYSTEM | Jul 18, 2006 | Substantially Equivalent |
| K023487 | HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAME | Mar 20, 2003 | Substantially Equivalent |
| K013882 | OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I | Apr 17, 2002 | Substantially Equivalent |
| K020371 | UPLINK TEST SYSTEM | Apr 3, 2002 | Substantially Equivalent |
| K011057 | INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX | Jun 6, 2001 | Substantially Equivalent |
| K001976 | STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I | Dec 6, 2000 | Substantially Equivalent |
| K002010 | STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421 | Nov 29, 2000 | Substantially Equivalent |
| K000399 | STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541 | May 15, 2000 | Substantially Equivalent |
| K001197 | COCAINE METABOLITE INTERCEPT MICRO-PLATE EIA | May 11, 2000 | Substantially Equivalent |