FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DAC-CEL T3 UPTAKE
K Number: K810212
·
Decision Feb 10, 1981
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
92
Applicant Total
17
Review Days
14
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Basic Information
- Device Name
- DAC-CEL T3 UPTAKE
- K Number
- K810212
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1715
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Burroughs Wellcome Co.
- Date Received
- January 27, 1981
- Decision Date
- February 10, 1981
- 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
Other 510(k) clearances with the same product code (KHQ), ordered by most recent decision date.
ACE T UPTAKE REAGENT TU CALIBRATORS
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T-UPTAKE MICROPLATE EIA
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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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ELECSYS T-UPTAKE ASSAY
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CEDIA T UPTAKE ASSAY
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Other Clearances by Burroughs Wellcome Co.
| K Number | Device Name | ||
|---|---|---|---|
| K820069 | WELLCOGEN GROUP B | Feb 18, 1982 | Substantially Equivalent |
| K813508 | SAC-CEL | Dec 29, 1981 | Substantially Equivalent |
| K810215 | DAC-CEL HCG | Apr 17, 1981 | Substantially Equivalent |
| K810214 | DAC-CEL DIAGNATAL | Mar 6, 1981 | Substantially Equivalent |
| K810213 | DAC-CEL TSH | Feb 10, 1981 | Substantially Equivalent |
| K791231 | DAC-CEL T4 | Sep 4, 1979 | Substantially Equivalent |
| K791232 | DAC-CEL T3 | Sep 4, 1979 | Substantially Equivalent |
| K781607 | STREP-TEX | Oct 17, 1978 | Substantially Equivalent |
| K780873 | THYMUNE-M | Jun 14, 1978 | Substantially Equivalent |
| K780874 | THYMUNE-T | Jun 14, 1978 | Substantially Equivalent |