FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RPMI 1640 AGAR W/MOPS AND 2% GLUCOSE
K Number: K072827
·
Decision Nov 26, 2007
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
0
Applicant Total
17
Review Days
54
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Basic Information
- Device Name
- RPMI 1640 AGAR W/MOPS AND 2% GLUCOSE
- K Number
- K072827
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.1700
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Remel, Inc.
- Date Received
- October 3, 2007
- Decision Date
- November 26, 2007
- Product Code
- MJE
- 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 |
|---|---|---|---|
| MJE | Culture Media, Antifungal, Susceptibility Test | FDA class 2 | Microbiology |
Other Clearances by Remel, Inc.
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|---|---|---|---|
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| K092407 | REMEL SPECTRA MRSA | Oct 8, 2010 | Substantially Equivalent |
| K041951 | XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B | Nov 15, 2004 | Substantially Equivalent |
| K033479 | PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY | Feb 26, 2004 | Substantially Equivalent |
| K031942 | XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020 | Nov 18, 2003 | Substantially Equivalent |
| K031965 | XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020 | Nov 14, 2003 | Substantially Equivalent |
| K031834 | XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY | Nov 10, 2003 | Substantially Equivalent |
| K031565 | XPECT INFLUENZA A/B | Jul 17, 2003 | Substantially Equivalent |
| K981391 | PAR-ONE | Jul 14, 1998 | Substantially Equivalent |