FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IQ TUPTAKE ASSAY
K Number: K931294
·
Decision Jul 22, 1993
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
92
Applicant Total
10
Review Days
129
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- IQ TUPTAKE ASSAY
- K Number
- K931294
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1715
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Becton Dickinson Advanced Diagnostics
- Date Received
- March 15, 1993
- Decision Date
- July 22, 1993
- 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
FDA 510(k)
FDA Class 2
·Clinical Chemistry
T-UPTAKE MICROPLATE EIA
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CHIRON DIAGNOSTICS ACS:180TU P
FDA 510(k)
FDA Class 2
·Clinical Chemistry
VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAKE CALIBRATORS (GEM.C025)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ELECSYS T-UPTAKE ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CEDIA T UPTAKE ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Becton Dickinson Advanced Diagnostics
| K Number | Device Name | ||
|---|---|---|---|
| K935667 | QTEST(R) STREP | Apr 21, 1994 | Substantially Equivalent |
| K931295 | IQ TT4 ASSAY | Jul 20, 1993 | Substantially Equivalent |
| K926356 | PRECISE(TM) HCG(URINE/SERUM) AND PRCISE(TM) PREG | Mar 18, 1993 | Substantially Equivalent |
| K925132 | BECTON DICKINSON THYROID STIMULATING HORMONE SYSTE | Dec 28, 1992 | Substantially Equivalent |
| K923673 | PRECISE STREP A | Sep 28, 1992 | Substantially Equivalent |
| K923060 | IQ IMMUNOCHEMISTRY SISTEM; IQ TSH ASSAY | Sep 15, 1992 | Substantially Equivalent |
| K914958 | RIATRAC PLUS | Mar 18, 1992 | Substantially Equivalent |
| K915197 | PRECISE TM HCG | Dec 17, 1991 | Substantially Equivalent |
| K915200 | PRECISE TM HCG FOR USE IN THE PHYSICIANS OFFICE LA | Dec 16, 1991 | Substantially Equivalent |