FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BARTELS CLOSTRIDIUM DIFFICILE TOXIN A ENZYM IMMUN
K Number: K913229
·
Decision Aug 29, 1991
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
41
Applicant Total
72
Review Days
38
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Basic Information
- Device Name
- BARTELS CLOSTRIDIUM DIFFICILE TOXIN A ENZYM IMMUN
- K Number
- K913229
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Baxter Diagnostics, Inc.
- Date Received
- July 22, 1991
- Decision Date
- August 29, 1991
- Product Code
- LLH
- 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 |
|---|---|---|---|
| LLH | Reagents, Clostridium Difficile Toxin | FDA class 1 | Microbiology |
Similar 510(k) Clearances
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Other Clearances by Baxter Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K934458 | DRIED GRAM-POSITIVE MIC/COMBO PANELS | Jul 18, 1995 | Substantially Equivalent |
| K950817 | DRIED GRAM POSITIVE MIC/COMBO PANELS/PNEUMOCOCCI | Apr 25, 1995 | Substantially Equivalent |
| K935704 | DRIED GRAM-NEGATIVE MIC//COMBO PANELS | Apr 14, 1995 | Substantially Equivalent |
| K950570 | STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAY | Apr 11, 1995 | Substantially Equivalent |
| K945235 | DRIED GRAM-POSITIVE MIC/COMBO PANELS | Mar 7, 1995 | Substantially Equivalent |
| K941030 | DRIED GRAM-NEGATIVE CEFPODOXIME | Feb 16, 1995 | Substantially Equivalent |
| K940917 | LORACARBEF GRAM-NAGATIVE PANELS | Feb 8, 1995 | Substantially Equivalent |
| K941459 | GRAM POSITIVE DRIED OVERNIGHT PANELS/LOMEFLOX | Feb 3, 1995 | Substantially Equivalent |
| K941317 | DRIED GRAM NEGATIVE/CEFMETAZOLE | Jan 31, 1995 | Substantially Equivalent |
| K942089 | MICRODILUTION/LORACARBEF PANELS | Jan 9, 1995 | Substantially Equivalent |