FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FLUROMETER, DADE
K Number: K782150
·
Decision Feb 15, 1979
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
13
Applicant Total
44
Review Days
51
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
- FLUROMETER, DADE
- K Number
- K782150
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.4520
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Dade, Baxter Travenol Diagnostics, Inc.
- Date Received
- December 26, 1978
- Decision Date
- February 15, 1979
- Product Code
- JZT
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| JZT | Fluorometer | FDA class 1 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JZT), ordered by most recent decision date.
ZYMMUNE AUTOREADER-F FLUORESCENCE MICROPLATE READER
FDA 510(k)
FDA Class 1
·Immunology
QLIA IMMUNOCHEMISTRY SYSTEM
FDA 510(k)
FDA Class 1
·Immunology
STAT-20 FLUOROMETER
FDA 510(k)
FDA Class 1
·Immunology
FLUORESCENCE CONCENTRATION ANALYZER (FCA)
FDA 510(k)
FDA Class 1
·Immunology
THE FIAX 5000 FLUOROMETER
FDA 510(k)
FDA Class 1
·Immunology
PHOTON ELITE/AUTOMATED RANDOM ACCESS IM/CH SYSTEM
FDA 510(k)
FDA Class 1
·Immunology
Other Clearances by Dade, Baxter Travenol Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K800296 | WHOLE BLOOD GAS CONTROL, LEVELS 1,2,&3 | Mar 5, 1980 | Substantially Equivalent |
| K792606 | WHOLE BLOOD PLATELET CONTROL NORMAL, | Feb 13, 1980 | Substantially Equivalent |
| K792723 | BLOOD FLUID FILTERS | Jan 21, 1980 | Substantially Equivalent |
| K792607 | T3 UPTAKE (T3U) REAGENTS | Jan 16, 1980 | Substantially Equivalent |
| K792443 | TSH RADIOIMMUNOASSAY | Dec 27, 1979 | Substantially Equivalent |
| K792442 | FERRITIN RADIOIMMUNOASSAY | Dec 18, 1979 | Substantially Equivalent |
| K791922 | HARLECO BRAND CLINICARD LIPASE TEST SET | Nov 27, 1979 | Substantially Equivalent |
| K792183 | DADE HIGH DENSITY LIPOPROTEIN CHOLESTERO | Nov 13, 1979 | Substantially Equivalent |
| K790767 | IMMU-TEK AUTOMATIC CENTRIFUGE | May 23, 1979 | Substantially Equivalent |
| K790776 | DADE LOW IONIC STRENGTH SOLUITION (LISS) | May 23, 1979 | Substantially Equivalent |