FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TOTAL IRON IN SERUM
K Number: K782160
·
Decision Jan 26, 1979
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
66
Applicant Total
89
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
- TOTAL IRON IN SERUM
- K Number
- K782160
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1410
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Fisher Scientific Co., LLC
- Date Received
- December 21, 1978
- Decision Date
- January 26, 1979
- Product Code
- JIY
- 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 |
|---|---|---|---|
| JIY | Photometric Method, Iron (Non-Heme) | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JIY), ordered by most recent decision date.
DIMENSION VISTA IRON FLEX REAGENT CARTRIDGE AND CALIBRATOR
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DIMENSION IRON FLEX REAGENT CARTRIDGE (IRON-DF85)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SENTINEL IRON LIQUID
FDA 510(k)
FDA Class 1
·Clinical Chemistry
VITALAB IRON REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
IRON-PC-SL ASSAY MODEL # 151-10, 151-26
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Fisher Scientific Co., LLC
| K Number | Device Name | ||
|---|---|---|---|
| K930415 | MICROHEMATOCRIT ROTOR | Mar 23, 1993 | Substantially Equivalent |
| K915825 | MARATHON 6K GENERAL-PURPOSE CENTRIFUGE | Mar 11, 1992 | Substantially Equivalent |
| K915441 | MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGE | Jan 8, 1992 | Substantially Equivalent |
| K890534 | MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1 | Mar 8, 1989 | Substantially Equivalent |
| K881275 | URIQUAL(TM) URINALYSIS CONTROLS (HUMAN) I & II | May 16, 1988 | Substantially Equivalent |
| K874054 | FISHER DIAGNOSTICS HEMATALL III LAS REAGENT | Oct 20, 1987 | Substantially Equivalent |
| K872916 | HISTOMATIC SLIDE STAINER, CODE-ON VERSION | Sep 14, 1987 | Substantially Equivalent |
| K871058 | SERACHEM LIQUID SPINAL FLUID CONTROL (HUMAN) | Apr 6, 1987 | Substantially Equivalent |
| K863224 | HEMATALL-C PLUS HEMATOLOGY CONTROLS | Oct 29, 1986 | Substantially Equivalent |
| K862318 | FISHER DIAGNOSTICS HEMATALL-C CALIBRATOR | Jul 10, 1986 | Substantially Equivalent |