FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VENTREZYME T3 IMMUNOASSAY T3
K Number: K853703
·
Decision Oct 4, 1985
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
143
Applicant Total
8
Review Days
30
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Basic Information
- Device Name
- VENTREZYME T3 IMMUNOASSAY T3
- K Number
- K853703
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1710
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Vxr, Inc.
- Date Received
- September 4, 1985
- Decision Date
- October 4, 1985
- Product Code
- CDP
- 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 |
|---|---|---|---|
| CDP | Radioimmunoassay, Total Triiodothyronine | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CDP), ordered by most recent decision date.
REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104)
FDA 510(k)
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·Clinical Chemistry
CHIRON DIAGNOSTICS ACS: 180 FT3
FDA 510(k)
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TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005
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·Clinical Chemistry
AIA-PACK FT3 ASSAY
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FDA Class 2
·Clinical Chemistry
OPTICOAT T3 EIA KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ABBOTT ARCHITECT FREE T3
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Vxr, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K853748 | VENTRESCREEN HCG URINE | Oct 1, 1985 | Substantially Equivalent |
| K841456 | VENTREXYME EIA CONTROLS IMMUNOASSAY | May 21, 1984 | Substantially Equivalent |
| K840473 | VENTREZYME T4 IMMUNOASSAY T4 | Apr 4, 1984 | Substantially Equivalent |
| K833960 | VENTREX PREGNANCY TEST KIT ENZYME | Feb 3, 1984 | Substantially Equivalent |
| K833989 | VENTREZYME THEOPHYLLINE IMMUNOASSAY | Jan 30, 1984 | Substantially Equivalent |
| K833878 | VENTREZYME DIGOXIN IMMUNOASSAY DIGOX | Jan 13, 1984 | Substantially Equivalent |
| K833909 | VENTRESCREEN BETA-HCG ENZYME IMMUNO | Nov 21, 1983 | Substantially Equivalent |