FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STAPH TRAC
K Number: K813614
·
Decision Feb 4, 1982
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
19
Applicant Total
23
Review Days
37
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Basic Information
- Device Name
- STAPH TRAC
- K Number
- K813614
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Dms Laboratories
- Date Received
- December 29, 1981
- Decision Date
- February 4, 1982
- 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
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STAPHYTECT PLUS/DRYSPOT STAPHYTECT PLUS
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REMEL STAPH LATEX KIT
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STAPHAUREX PLUS(TM)
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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 Dms Laboratories
| K Number | Device Name | ||
|---|---|---|---|
| K831186 | RAPID NFT | May 9, 1983 | Substantially Equivalent |
| K831187 | TRP | May 9, 1983 | Substantially Equivalent |
| K830437 | CHS | Mar 17, 1983 | Substantially Equivalent |
| K823102 | AGAR P | Dec 3, 1982 | Substantially Equivalent |
| K821038 | FAST VIOLET B | May 27, 1982 | Substantially Equivalent |
| K813612 | RAPID ZYME | Feb 22, 1982 | Substantially Equivalent |
| K813613 | RAPID CH | Feb 22, 1982 | Substantially Equivalent |
| K820213 | SALINE SOLUTION | Feb 12, 1982 | Substantially Equivalent |
| K820209 | ZYME B | Feb 12, 1982 | Substantially Equivalent |
| K820212 | OXI | Feb 12, 1982 | Substantially Equivalent |