FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LEECO T3% DIAGNOSTIC KIT
K Number: K822575
·
Decision Sep 30, 1982
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
92
Applicant Total
49
Review Days
36
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
- LEECO T3% DIAGNOSTIC KIT
- K Number
- K822575
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1715
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Leeco Diagnostics, Inc.
- Date Received
- August 25, 1982
- Decision Date
- September 30, 1982
- 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 Leeco Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K895765 | LEECO PREVIEW(R) EBV (EIA) | Oct 31, 1989 | Substantially Equivalent |
| K894122 | LEECO VIS-DISK STREP-A (EIA) | Aug 15, 1989 | Substantially Equivalent |
| K891095 | VIS-DISK HCG (EIA) LYOPHILIZED JPL-044M | Jun 16, 1989 | Substantially Equivalent |
| K891096 | VIS-DISK HCG (EIA) JPL-041M | Jun 16, 1989 | Substantially Equivalent |
| K883269 | PRL-QUANT | Sep 13, 1988 | Substantially Equivalent |
| K880577 | CONCEP-7-BHCG | Mar 15, 1988 | Substantially Equivalent |
| K880069 | LEECO PREGNASTICK (EIA) CATALOG #003 | Feb 11, 1988 | Substantially Equivalent |
| K870259 | VIS-CUBE HCG (EIA) LYOPHILIZED JPL-044 | Mar 10, 1987 | Substantially Equivalent |
| K864170 | LEECO VIS-CUBE STREP A (EIA) | Feb 3, 1987 | Substantially Equivalent |
| K863999 | VIS-CUBE PREGNANCY HOME TEST,CAT. # JPL-042 | Jan 9, 1987 | Substantially Equivalent |