FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
REMEL STAPH LATEX KIT
K Number: K964315
·
Decision Feb 7, 1997
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
19
Applicant Total
10
Review Days
101
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Basic Information
- Device Name
- REMEL STAPH LATEX KIT
- K Number
- K964315
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Remel, L.P.
- Date Received
- October 29, 1996
- Decision Date
- February 7, 1997
- 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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STAPHAUREX PLUS(TM)
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STAPH-A-LEX(TM) SYSTEM
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SLIDEX STAPH-KIT
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VISI-STAPH
FDA 510(k)
FDA Class 1
·Microbiology
Other Clearances by Remel, L.P.
| K Number | Device Name | ||
|---|---|---|---|
| K972359 | REMEL BILE ESCULIN AZIDE AGAR W/6 MCG/ML VANCOMYCIN | Aug 28, 1997 | Substantially Equivalent |
| K964421 | REMEL MEROPENEM 10UG SUSCEPTIBILITY DISK | Dec 6, 1996 | Substantially Equivalent |
| K961046 | 10B ARGININE BROTH | Sep 18, 1996 | Substantially Equivalent |
| K955143 | RPR LIQUID CONTROLS | Jul 30, 1996 | Substantially Equivalent |
| K955136 | RPR CARD TEST KIT | Jul 29, 1996 | Substantially Equivalent |
| K961818 | GENTAMICIN DISK (120MCG) | Jul 10, 1996 | Substantially Equivalent |
| K961819 | STREPTOMYCIN DISK (300MCG) | Jul 10, 1996 | Substantially Equivalent |
| K960313 | MUELLER HINTON AGAR WITH 2% NACI | Mar 25, 1996 | Substantially Equivalent |
| K954986 | GC BASE W/ 1% GCHI | Feb 16, 1996 | Substantially Equivalent |