FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MODIFICATION OF EST CULTURE SYSTEM II - MYCO
K Number: K972756
·
Decision Aug 1, 1997
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
67
Applicant Total
12
Review Days
63
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Basic Information
- Device Name
- MODIFICATION OF EST CULTURE SYSTEM II - MYCO
- K Number
- K972756
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2560
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Accumed Intl., Inc.
- Date Received
- May 30, 1997
- Decision Date
- August 1, 1997
- Product Code
- MDB
- 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 |
|---|---|---|---|
| MDB | System, Blood Culturing | FDA class 1 | Microbiology |
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|---|---|---|---|
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| K983301 | SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH TROVAFLOXACIN | Nov 25, 1998 | Substantially Equivalent |
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| K972576 | GRAM POSITIVE AUTOIDENTIFICATION PLATES, SENSITITRE AP90 | Jan 22, 1998 | Substantially Equivalent |
| K964689 | TRACCELL 2000 SLIDE MAPPING SYSTEM | Aug 18, 1997 | Substantially Equivalent |
| K965190 | SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE MIC PLATE | Mar 19, 1997 | Substantially Equivalent |
| K960366 | SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES | Apr 9, 1996 | Substantially Equivalent |