FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
SERUM TRANSPORT VIALS, T25/SC, TZ10/SC
K Number: K851506
·
Decision Jun 27, 1985
Classifications
1
FEI Numbers
218
Registration Numbers
218
Same Product Code
235
Applicant Total
15
Review Days
73
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Basic Information
- Device Name
- SERUM TRANSPORT VIALS, T25/SC, TZ10/SC
- K Number
- K851506
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1675
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Ncs Diagnostics, Inc.
- Date Received
- April 15, 1985
- Decision Date
- June 27, 1985
- Product Code
- JKA
- Advisory Committee
- Clinical Chemistry
- 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 |
|---|---|---|---|
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | FDA class 2 | Clinical Chemistry |
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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 |
| 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 |