FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BENZODIAZEPINE ENZYME IMMUNOASSAY
K Number: K930529
·
Decision Aug 5, 1993
Classifications
1
FEI Numbers
90
Registration Numbers
90
Same Product Code
89
Applicant Total
66
Review Days
184
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Basic Information
- Device Name
- BENZODIAZEPINE ENZYME IMMUNOASSAY
- K Number
- K930529
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3170
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Diagnostic Reagents, Inc.
- Date Received
- February 2, 1993
- Decision Date
- August 5, 1993
- Product Code
- JXM
- 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 |
|---|---|---|---|
| JXM | Enzyme Immunoassay, Benzodiazepine | FDA class 2 | Clinical Toxicology |
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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 |