FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOTROL RUB-E.I.A. TEST G
K Number: K894544
·
Decision Aug 30, 1989
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
93
Applicant Total
46
Review Days
41
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Basic Information
- Device Name
- BIOTROL RUB-E.I.A. TEST G
- K Number
- K894544
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3510
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Biotrol, USA, Inc.
- Date Received
- July 20, 1989
- Decision Date
- August 30, 1989
- Product Code
- LFX
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | FDA class 2 | Microbiology |
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|---|---|---|---|
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| 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 |
| K891061 | BIOTROL CALCIUM MONOREACTIF | Aug 10, 1989 | Substantially Equivalent |
| K891286 | BIOTROL CHEMISTRY URINE CONTROL | Apr 10, 1989 | Substantially Equivalent |