FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACETAMINOPHEN SERUM TOX EIA ASSAY
K Number: K961373
·
Decision Jul 8, 1996
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
35
Applicant Total
66
Review Days
90
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
- ACETAMINOPHEN SERUM TOX EIA ASSAY
- K Number
- K961373
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3030
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Diagnostic Reagents, Inc.
- Date Received
- April 9, 1996
- Decision Date
- July 8, 1996
- Product Code
- LDP
- 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 |
|---|---|---|---|
| LDP | Colorimetry, Acetaminophen | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LDP), ordered by most recent decision date.
Acetaminophen
FDA 510(k)
FDA Class 2
·Clinical Toxicology
SEKURE Acetaminophen L3K Assay
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ROCHE ACETAMINOPHEN ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30
FDA 510(k)
FDA Class 2
·Clinical Toxicology
DIMENSION VISTA FLEX REAGENT CARTRIDGES
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Other Clearances by Diagnostic Reagents, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K983268 | MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAY | Nov 18, 1998 | Substantially Equivalent |
| K983812 | NAPA EIA ASSAY | Nov 16, 1998 | Substantially Equivalent |
| K983323 | DIGOXIN IMMUNOASSAY | Nov 12, 1998 | Substantially Equivalent |
| K983280 | VANCOMYCIN EIA ASSAY | Nov 6, 1998 | Substantially Equivalent |
| K983159 | DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLS | Nov 5, 1998 | Substantially Equivalent |
| K973102 | LIDOCAINE EIA ASSAY | Sep 12, 1997 | Substantially Equivalent |
| K972835 | 50NG/ML COCAINE METABOLITE CALIBRATOR | Aug 28, 1997 | Substantially Equivalent |
| K972526 | METHADONE EIA ASSAY | Aug 4, 1997 | Substantially Equivalent |
| K964212 | QUINIDINE ENZYME IMMUNOASSAY | Dec 18, 1996 | Substantially Equivalent |
| K963835 | DIGOXIN ENZYME IMMUNOASSAY | Dec 10, 1996 | Substantially Equivalent |