FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DBEST OPIATES TEST KIT
K Number: K983190
·
Decision Nov 18, 1998
Classifications
1
FEI Numbers
100
Registration Numbers
100
Same Product Code
214
Applicant Total
17
Review Days
68
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
- DBEST OPIATES TEST KIT
- K Number
- K983190
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3650
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ameritek, Inc.
- Date Received
- September 11, 1998
- Decision Date
- November 18, 1998
- Product Code
- DJG
- 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 |
|---|---|---|---|
| DJG | Enzyme Immunoassay, Opiates | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DJG), ordered by most recent decision date.
Labcorp Fentanyl Urine Visual Test
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Evidence MultiSTAT DOA Urine MultiPlex
FDA 510(k)
FDA Class 2
·Clinical Toxicology
LZI Buprenorphine II Enzyme Immunoassay
FDA 510(k)
FDA Class 2
·Clinical Toxicology
SEFRIA Hydrocodone Oral Fluid
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
LZI Fentanyl III Enzyme Immunoassay
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Other Clearances by Ameritek, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K001215 | DBEST HCG 2 IU/ML TEST KIT | Jun 22, 2000 | Substantially Equivalent |
| K990873 | DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USE | Sep 1, 1999 | Substantially Equivalent |
| K990681 | DBSET MULTIDRUG SCREEN TEST KIT | Jul 15, 1999 | Substantially Equivalent |
| K984269 | DBEST OCCULT BLOOD TEST KIT | May 11, 1999 | Substantially Equivalent |
| K983191 | DBEST COCAINE TEST KIT | Nov 18, 1998 | Substantially Equivalent |
| K983188 | DBEST TETRAHYDROCANNABINOL TEST KIT | Nov 18, 1998 | Substantially Equivalent |
| K983189 | DBEST METHAMPHETAMINES TEST KIT | Nov 18, 1998 | Substantially Equivalent |
| K981504 | DBEST AMPHETAMINES TEST KIT | Aug 6, 1998 | Substantially Equivalent |
| K974508 | DBEST ONE-STEP OVULATION TEST | Feb 2, 1998 | Substantially Equivalent |
| K973957 | DBEST ONE-STEP HCG SERUM/URINE TEST | Dec 17, 1997 | Substantially Equivalent |