FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
T3 UPTAKE RADIOIMMUNOASSAY KIT
K Number: K855169
·
Decision Feb 6, 1986
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
92
Applicant Total
14
Review Days
42
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Basic Information
- Device Name
- T3 UPTAKE RADIOIMMUNOASSAY KIT
- K Number
- K855169
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1715
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Cambridge Medical Technology
- Date Received
- December 26, 1985
- Decision Date
- February 6, 1986
- 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 |
Similar 510(k) Clearances
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CHIRON DIAGNOSTICS ACS:180TU P
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VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAKE CALIBRATORS (GEM.C025)
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Other Clearances by Cambridge Medical Technology
| K Number | Device Name | ||
|---|---|---|---|
| K890837 | RIA-GNOST INSULIN | Apr 26, 1989 | Substantially Equivalent |
| K890836 | RIA-GNOST PROGESTERONE | Mar 16, 1989 | Substantially Equivalent |
| K890697 | RIA-GNOST FERRITIN | Mar 16, 1989 | Substantially Equivalent |
| K873737 | NO SPIN(TM) T3 COATED TUBE RADIOIMMUNOASSAY | Nov 24, 1987 | Substantially Equivalent |
| K870573 | T4 NO SPIN(TM) COATED TUBE RADIOIMMUNOASSAY KIT | Apr 22, 1987 | Substantially Equivalent |
| K862871 | RADIOIMMUNOASSAY OF NO SPIN(TM) CORTISOL | Aug 19, 1986 | Substantially Equivalent |
| K860130 | TESTOSTERONE COATED TUBES RADIOIMMUNOASSAY KIT | Feb 19, 1986 | Substantially Equivalent |
| K850254 | PARATHYROID HORMONE RADIOIMMUNOASSAY KIT | Apr 3, 1985 | Substantially Equivalent |
| K843635 | MATCHED COMPONENT SET FOR RADIOIMMUNO- | Sep 28, 1984 | Substantially Equivalent |
| K841042 | MATCHED COMPONENT SET RADIOIMMUNOASSAY | Apr 19, 1984 | Substantially Equivalent |