FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIO MAG TOTAL T4 RADIOIMMUNOASSAY KIT
K Number: K823004
·
Decision Nov 5, 1982
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
120
Applicant Total
9
Review Days
24
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Basic Information
- Device Name
- BIO MAG TOTAL T4 RADIOIMMUNOASSAY KIT
- K Number
- K823004
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1700
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Bioclinical Group
- Date Received
- October 12, 1982
- Decision Date
- November 5, 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
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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 Bioclinical Group
| K Number | Device Name | ||
|---|---|---|---|
| K862968 | FREE T3 RADIOIMMUNOASSAY KIT | Sep 25, 1986 | Substantially Equivalent |
| K853837 | LH/FSH RADIOIMMUNOASSAY KIT | Oct 16, 1985 | Substantially Equivalent |
| K832638 | CORTISOL RADIOIMMUNOASSAY KIT | Sep 12, 1983 | Substantially Equivalent |
| K823005 | BIO MAG FREE T4 RADIOIMMUNOASSAY KIT | Dec 15, 1982 | Substantially Equivalent |
| K822840 | RADIOIMMUNOASSAY, HUMAN CHORRIONIC | Oct 27, 1982 | Substantially Equivalent |
| K822515 | B-HCG RADIOIMMUNOASSAY KIT | Sep 14, 1982 | Substantially Equivalent |
| K821241 | FREE T4 RADIOIMMUNOASSAY KIT | Jun 1, 1982 | Substantially Equivalent |
| K821101 | TOTAL RADIOIMMUNOASSAY KIT | May 5, 1982 | Substantially Equivalent |