FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DOUBLE ANTIBODY SERUM BENZODIAZEPINES
K Number: K890001
·
Decision Jan 24, 1989
Classifications
1
FEI Numbers
90
Registration Numbers
90
Same Product Code
89
Applicant Total
321
Review Days
21
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Basic Information
- Device Name
- DOUBLE ANTIBODY SERUM BENZODIAZEPINES
- K Number
- K890001
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3170
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Diagnostic Products Corp.
- Date Received
- January 3, 1989
- Decision Date
- January 24, 1989
- 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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| K022118 | IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS) | Jul 22, 2002 | Substantially Equivalent |
| K021257 | ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS) | Jun 3, 2002 | Substantially Equivalent |
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