FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇦 Canada
KULTSURE STARSWAB(M240), MODIFICATION
K Number: K943499
·
Decision Nov 30, 1994
Classifications
1
FEI Numbers
74
Registration Numbers
74
Same Product Code
110
Applicant Total
15
Review Days
170
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Basic Information
- Device Name
- KULTSURE STARSWAB(M240), MODIFICATION
- K Number
- K943499
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2390
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ncs Diagnostics, Inc.
- Date Received
- June 13, 1994
- Decision Date
- November 30, 1994
- Product Code
- JSM
- 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 |
|---|---|---|---|
| JSM | Culture Media, Non-Propagating Transport | 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 |
| K882811 | STREPSLIDE | Oct 25, 1988 | 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 |