FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOTROL CALCIUM MONOREACTIF
K Number: K891061
·
Decision Aug 10, 1989
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
46
Applicant Total
46
Review Days
162
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Basic Information
- Device Name
- BIOTROL CALCIUM MONOREACTIF
- K Number
- K891061
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1145
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Biotrol, USA, Inc.
- Date Received
- March 1, 1989
- Decision Date
- August 10, 1989
- Product Code
- CJY
- 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 |
|---|---|---|---|
| CJY | Azo Dye, Calcium | FDA class 2 | Clinical Chemistry |
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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 |
| K912795 | BIOTROL UIBC REAGENT | Aug 12, 1991 | 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 |
| K891286 | BIOTROL CHEMISTRY URINE CONTROL | Apr 10, 1989 | Substantially Equivalent |