FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LEECO T4 QUANT DIAGNOSTICS TEST KIT
K Number: K822399
·
Decision Sep 13, 1982
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
120
Applicant Total
49
Review Days
34
Basic Information
- Device Name
- LEECO T4 QUANT DIAGNOSTICS TEST KIT
- K Number
- K822399
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1700
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- LEECO DIAGNOSTICS, INC.
- Date Received
- August 10, 1982
- Decision Date
- September 13, 1982
- Product Code
- CDX
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| CDX | Radioimmunoassay, Total Thyroxine | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CDX), ordered by most recent decision date.
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TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116
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STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by LEECO DIAGNOSTICS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K895765 | LEECO PREVIEW(R) EBV (EIA) | Oct 31, 1989 | Substantially Equivalent |
| K894122 | LEECO VIS-DISK STREP-A (EIA) | Aug 15, 1989 | Substantially Equivalent |
| K891096 | VIS-DISK HCG (EIA) JPL-041M | Jun 16, 1989 | Substantially Equivalent |
| K891095 | VIS-DISK HCG (EIA) LYOPHILIZED JPL-044M | Jun 16, 1989 | Substantially Equivalent |
| K883269 | PRL-QUANT | Sep 13, 1988 | Substantially Equivalent |
| K880577 | CONCEP-7-BHCG | Mar 15, 1988 | Substantially Equivalent |
| K880069 | LEECO PREGNASTICK (EIA) CATALOG #003 | Feb 11, 1988 | Substantially Equivalent |
| K870259 | VIS-CUBE HCG (EIA) LYOPHILIZED JPL-044 | Mar 10, 1987 | Substantially Equivalent |
| K864170 | LEECO VIS-CUBE STREP A (EIA) | Feb 3, 1987 | Substantially Equivalent |
| K863999 | VIS-CUBE PREGNANCY HOME TEST,CAT. # JPL-042 | Jan 9, 1987 | Substantially Equivalent |