FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOTROL TOXO ELISA TEST G
K Number: K873294
·
Decision Apr 12, 1988
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
105
Applicant Total
46
Review Days
239
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Basic Information
- Device Name
- BIOTROL TOXO ELISA TEST G
- K Number
- K873294
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3780
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Biotrol, USA, Inc.
- Date Received
- August 17, 1987
- Decision Date
- April 12, 1988
- Product Code
- LGD
- 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 |
|---|---|---|---|
| LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | FDA class 2 | Microbiology |
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Other Clearances by Biotrol, USA, Inc.
| K Number | Device Name | ||
|---|---|---|---|
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| 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 |
| K891061 | BIOTROL CALCIUM MONOREACTIF | Aug 10, 1989 | Substantially Equivalent |