FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇦 Canada
STAPHSLIDE
K Number: K874019
·
Decision Oct 28, 1987
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
19
Applicant Total
15
Review Days
26
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- STAPHSLIDE
- K Number
- K874019
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Ncs Diagnostics, Inc.
- Date Received
- October 2, 1987
- Decision Date
- October 28, 1987
- Product Code
- JWX
- 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 |
|---|---|---|---|
| JWX | Kit, Screening, Staphylococcus Aureus | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JWX), ordered by most recent decision date.
BINAXNOX STAPHYLOCOCCUS AUREUS TEST
FDA 510(k)
FDA Class 1
·Microbiology
STAPHYTECT PLUS/DRYSPOT STAPHYTECT PLUS
FDA 510(k)
FDA Class 1
·Microbiology
REMEL STAPH LATEX KIT
FDA 510(k)
FDA Class 1
·Microbiology
STAPHAUREX PLUS(TM)
FDA 510(k)
FDA Class 1
·Microbiology
STAPH-A-LEX(TM) SYSTEM
FDA 510(k)
FDA Class 1
·Microbiology
SLIDEX STAPH-KIT
FDA 510(k)
FDA Class 1
·Microbiology
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 |
| 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 |