FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RIA KIT, QUANTITOPE T3 UPTAKE
K Number: K781905
·
Decision Jan 3, 1979
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
92
Applicant Total
92
Review Days
51
Basic Information
- Device Name
- RIA KIT, QUANTITOPE T3 UPTAKE
- K Number
- K781905
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1715
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- KALLESTAD LABORATORIES, INC.
- Date Received
- November 13, 1978
- Decision Date
- January 3, 1979
- Product Code
- KHQ
- 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 |
|---|---|---|---|
| KHQ | Radioassay, Triiodothyronine Uptake | FDA class 2 | Clinical Chemistry |
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Other Clearances by KALLESTAD LABORATORIES, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K863681 | PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEM | Dec 3, 1986 | Substantially Equivalent |
| K862917 | PATHFINDER ROTAVIRUS CHEMILUMINESCENT | Oct 22, 1986 | Substantially Equivalent |
| K863682 | PATHFINDER(TM) SPECIMEN COLLECTION KIT | Oct 10, 1986 | Substantially Equivalent |
| K862743 | PATHFINDER(TM) RESPIRATORY SYNCYTIAL VIRUS | Sep 29, 1986 | Substantially Equivalent |
| K862313 | KALLESTAD SM/RNP TEST REAGENT | Aug 6, 1986 | Substantially Equivalent |
| K862710 | KALLESTAD SSA/SSB ENA TEST REAGENTS | Jul 29, 1986 | Substantially Equivalent |
| K855014 | QUANTIMETRIC PLUS CALIBRATOR/CONTROL SET A | Mar 14, 1986 | Substantially Equivalent |
| K855010 | QUANTIMETRIC PLUS IGM REAGENT KIT | Feb 28, 1986 | Substantially Equivalent |
| K855012 | QUANTIMETRIC PLUS C4 REAGENT KIT | Feb 26, 1986 | Substantially Equivalent |
| K855007 | QUANTIMETRIC PLUS LAMBDA REAGENT KIT | Feb 26, 1986 | Substantially Equivalent |