FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PARAMAX(R) THEOPHYLLINE REAGENT AND CALIBRATORS
K Number: K932685
·
Decision Sep 24, 1993
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
70
Applicant Total
72
Review Days
113
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Basic Information
- Device Name
- PARAMAX(R) THEOPHYLLINE REAGENT AND CALIBRATORS
- K Number
- K932685
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3880
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Baxter Diagnostics, Inc.
- Date Received
- June 3, 1993
- Decision Date
- September 24, 1993
- Product Code
- KLS
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- TX
- 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 |
|---|---|---|---|
| KLS | Enzyme Immunoassay, Theophylline | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KLS), ordered by most recent decision date.
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FDA Class 2
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MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229
FDA 510(k)
FDA Class 2
·Clinical Toxicology
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 |