FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THEOFAST TEST KIT FOR QUANTITATIVE THEO
K Number: K834244
·
Decision Jan 24, 1984
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
70
Applicant Total
8
Review Days
48
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Basic Information
- Device Name
- THEOFAST TEST KIT FOR QUANTITATIVE THEO
- K Number
- K834244
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3880
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Allergenetics
- Date Received
- December 7, 1983
- Decision Date
- January 24, 1984
- Product Code
- KLS
- 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 |
|---|---|---|---|
| KLS | Enzyme Immunoassay, Theophylline | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KLS), ordered by most recent decision date.
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Other Clearances by Allergenetics
| K Number | Device Name | ||
|---|---|---|---|
| K851512 | ALLERGENETICS IGE FAST TEST | May 28, 1985 | Substantially Equivalent |
| K842970 | ALLERGENTICS TOTAL IGE/THEOPHYLLINE | Aug 29, 1984 | Substantially Equivalent |
| K842969 | ALLERGENETICS ALLER-SPECIFIC IGE SERUM | Aug 28, 1984 | Substantially Equivalent |
| K833418 | CHYMOFAST TEST | Mar 12, 1984 | Substantially Equivalent |
| K834594 | TOTAL IGE FAST TEST | Feb 10, 1984 | Substantially Equivalent |
| K833419 | LABELED 125I ANTI-IGE | Feb 3, 1984 | Substantially Equivalent |
| K822341 | ALLERGENETICS IGE-FAST TEST | Nov 10, 1982 | Substantially Equivalent |