FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇦 Canada
STREPSLIDE
K Number: K882811
·
Decision Oct 25, 1988
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
43
Applicant Total
15
Review Days
110
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Basic Information
- Device Name
- STREPSLIDE
- K Number
- K882811
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3740
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Ncs Diagnostics, Inc.
- Date Received
- July 7, 1988
- Decision Date
- October 25, 1988
- Product Code
- GTY
- 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 |
|---|---|---|---|
| GTY | Antigens, All Groups, Streptococcus Spp. | FDA class 1 | Microbiology |
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Other Clearances by Ncs Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K943498 | KULTSURE STARSWAB (M210), MODIFICATION | Nov 30, 1994 | Substantially Equivalent |
| K943499 | KULTSURE STARSWAB(M240), MODIFICATION | Nov 30, 1994 | Substantially Equivalent |
| K881209 | ASO SLIDE TEST | Apr 12, 1988 | Substantially Equivalent |
| K874019 | STAPHSLIDE | Oct 28, 1987 | Substantially Equivalent |
| K871404 | KULTSURE | Apr 21, 1987 | Substantially Equivalent |
| K870231 | KULTSURE | Feb 4, 1987 | Substantially Equivalent |
| K860178 | KULTSURE (CULTURE TRANSPORT) | Apr 4, 1986 | Substantially Equivalent |
| K860655 | KULTSURE (CATALOGUE NO. M200) | Mar 6, 1986 | Substantially Equivalent |
| K860657 | KULTSURE (CATALOGUE NO. M240) | Mar 4, 1986 | Substantially Equivalent |
| K860656 | KULTSURE (CATALOGUE NO. M210) | Mar 4, 1986 | Substantially Equivalent |