FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TEST, FERROZINE IRON & IRON BINDING
K Number: K770748
·
Decision Jun 1, 1977
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
45
Applicant Total
22
Review Days
40
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Basic Information
- Device Name
- TEST, FERROZINE IRON & IRON BINDING
- K Number
- K770748
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1415
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Hycel, Inc.
- Date Received
- April 22, 1977
- Decision Date
- June 1, 1977
- Product Code
- JMO
- 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 |
|---|---|---|---|
| JMO | Ferrozine (Colorimetric) Iron Binding Capacity | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JMO), ordered by most recent decision date.
ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT, ACE LIPASE REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541; CALIBRATOR KIT 4, MODEL 120 4668
FDA 510(k)
FDA Class 1
·Clinical Chemistry
VITROS CHEMISTRY PRODUCTS DTIBC REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524
FDA 510(k)
FDA Class 1
·Clinical Chemistry
WIENER LAB. FER-COLOR TRANSFERRINA, MODEL AUX. REAGENTS FOR 25 SAMPLES CAT. 1492002
FDA 510(k)
FDA Class 1
·Clinical Chemistry
BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Hycel, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K802422 | HYCEL TRIGYCERIDE II TEST | Oct 6, 1980 | Unknown |
| K790335 | HYCEL M | Feb 27, 1979 | Substantially Equivalent |
| K782116 | KETOSTEROID TEST, HYCEL-17 | Jan 26, 1979 | Substantially Equivalent |
| K782176 | HYCEL LDH-INT TEST | Jan 26, 1979 | Substantially Equivalent |
| K782102 | HYCEL COUNTER 211 | Jan 3, 1979 | Substantially Equivalent |
| K782100 | HYCEL COUNTER 333 | Jan 3, 1979 | Substantially Equivalent |
| K782101 | HYCEL COUNTER 222 | Jan 3, 1979 | Substantially Equivalent |
| K781004 | HMA URIC ACID TEST | Jul 27, 1978 | Substantially Equivalent |
| K780946 | ROYCO MODEL 970 HEMATOLOGY DATA ANALYZER | Jul 27, 1978 | Substantially Equivalent |
| K780464 | LELECTIVE KINETIC SYSTEM-60 | May 3, 1978 | Substantially Equivalent |