FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇦 Canada
SYNERMED UIBC REAGENT KIT
K Number: K922784
·
Decision Jul 21, 1992
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
45
Applicant Total
45
Review Days
42
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Basic Information
- Device Name
- SYNERMED UIBC REAGENT KIT
- K Number
- K922784
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1415
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Synermed, Inc.
- Date Received
- June 9, 1992
- Decision Date
- July 21, 1992
- 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 Synermed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K973109 | SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KIT | Sep 25, 1997 | Substantially Equivalent |
| K972716 | SYNERMED TOTAL BILIRUBIN REAGENT KIT | Aug 7, 1997 | Substantially Equivalent |
| K971491 | SYNERMED IR 200 CHEMISTRY ANALYZER | Jun 26, 1997 | Substantially Equivalent |
| K962479 | SYNERMED ISE REAGENTS | Mar 3, 1997 | Substantially Equivalent |
| K963939 | SYNERMED DIRECT BILIRUBIN REAGENT KIT | Dec 18, 1996 | Substantially Equivalent |
| K960793 | SYNERMED ENZYMATIC CO2 REAGENT KIT | Mar 11, 1996 | Substantially Equivalent |
| K953395 | SYNERMED CALCIUM REAGENT KIT | Aug 31, 1995 | Substantially Equivalent |
| K952179 | SYNERMED ISE REAGENTS | Jun 20, 1995 | Substantially Equivalent |
| K943924 | CREATININE-PO REAGENT KIT | Sep 20, 1994 | Substantially Equivalent |
| K941091 | SYNERMED AMYLASE REAGENT KIT | May 3, 1994 | Substantially Equivalent |