FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BIOTROL UIBC REAGENT
K Number: K912795
·
Decision Aug 12, 1991
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
45
Applicant Total
46
Review Days
48
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Basic Information
- Device Name
- BIOTROL UIBC REAGENT
- K Number
- K912795
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1415
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Biotrol, USA, Inc.
- Date Received
- June 25, 1991
- Decision Date
- August 12, 1991
- 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
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ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT, ACE LIPASE REAGENT
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VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541; CALIBRATOR KIT 4, MODEL 120 4668
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VITROS CHEMISTRY PRODUCTS DTIBC REAGENT
FDA 510(k)
FDA Class 1
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OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524
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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 Biotrol, USA, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K934014 | VACUSOL PLUS DENTAL VACUUM LINE CLEANER/DISINFECTANT | Dec 6, 1995 | Substantially Equivalent |
| K931141 | BIOTROL AMYLASE CNPG3 | May 26, 1993 | Substantially Equivalent |
| K921855 | BIOTROL BICARBONATE STANDARDS | Aug 3, 1992 | Substantially Equivalent |
| K921677 | BIOTROL MAGNESIUM (MAGON) | May 26, 1992 | Substantially Equivalent |
| K910721 | BIOTROL PROTEIN MULTILEVEL STANDARDS | May 6, 1991 | Substantially Equivalent |
| K905683 | BIOTROL LACTATE DEHYDROGENASE (L-P) | Mar 11, 1991 | Substantially Equivalent |
| K905280 | BIOTROL BILIRUBIN C & T CONTROL | Feb 4, 1991 | Substantially Equivalent |
| K894544 | BIOTROL RUB-E.I.A. TEST G | Aug 30, 1989 | Substantially Equivalent |
| K891061 | BIOTROL CALCIUM MONOREACTIF | Aug 10, 1989 | Substantially Equivalent |
| K891286 | BIOTROL CHEMISTRY URINE CONTROL | Apr 10, 1989 | Substantially Equivalent |