FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DADE (PAI-1) CHROMOGENIC ASSAY DADE COAGTROL-PAI
K Number: K933188
·
Decision Sep 22, 1993
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
179
Applicant Total
72
Review Days
84
Basic Information
- Device Name
- DADE (PAI-1) CHROMOGENIC ASSAY DADE COAGTROL-PAI
- K Number
- K933188
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5425
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BAXTER DIAGNOSTICS, INC.
- Date Received
- June 30, 1993
- Decision Date
- September 22, 1993
- Product Code
- JPA
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| JPA | System, Multipurpose For In Vitro Coagulation Studies | FDA class 2 | Hematology |
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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 |
| K942267 | DRIED GRAM-POSITIVE MIC/COMBO PANELS/CEFMETAZOLE | Jan 9, 1995 | Substantially Equivalent |