FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PYR SWAB
K Number: K970832
·
Decision Apr 24, 1997
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
243
Applicant Total
11
Review Days
48
Basic Information
- Device Name
- PYR SWAB
- K Number
- K970832
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- REMEL, INC.
- Date Received
- March 7, 1997
- Decision Date
- April 24, 1997
- Product Code
- JTO
- 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 |
|---|---|---|---|
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | FDA class 1 | Microbiology |
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|---|---|---|---|
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| K092407 | REMEL SPECTRA MRSA | Oct 8, 2010 | Substantially Equivalent |
| K072827 | RPMI 1640 AGAR W/MOPS AND 2% GLUCOSE | Nov 26, 2007 | Substantially Equivalent |
| K981391 | PAR-ONE | Jul 14, 1998 | Substantially Equivalent |
| K970834 | GRAM SWAB | Apr 17, 1997 | Substantially Equivalent |
| K970831 | REMEL SPARFLOXACIN 5G SUSCEPTIBILTY DISK | Apr 2, 1997 | Substantially Equivalent |
| K970830 | REMEL LEVOFLOXACIN 5G SUSCEPTIBILTY DISK | Apr 2, 1997 | Substantially Equivalent |
| K970833 | INDOLE SWAB | Apr 2, 1997 | Substantially Equivalent |
| K935975 | REMEL PIPERACILLIN/TAZOBACTAM 100/10 MCG | Sep 19, 1994 | Substantially Equivalent |