FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IRISTAIN FORMULA 2, PARTS 1 AND 2
K Number: K893530
·
Decision Jun 13, 1989
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
39
Applicant Total
14
Review Days
36
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Basic Information
- Device Name
- IRISTAIN FORMULA 2, PARTS 1 AND 2
- K Number
- K893530
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.1850
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Intl. Remote Imaging Systems
- Date Received
- May 8, 1989
- Decision Date
- June 13, 1989
- Product Code
- JTS
- Advisory Committee
- Hematology
- Review Advisory Committee
- PA
- 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 |
|---|---|---|---|
| JTS | Stains, Microbiologic | FDA class 1 | Hematology |
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| K Number | Device Name | ||
|---|---|---|---|
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| K972141 | THE YELLOW IRIS URINALYSIS WORKSTATION | Aug 25, 1997 | Substantially Equivalent |
| K953116 | WHITE IRIS LEUKOCYTE DIFFERENTIAL ANALYZER | May 13, 1996 | Substantially Equivalent |
| K960054 | 900UDX URINE PATHOLOGY SYSTEM | Mar 22, 1996 | Substantially Equivalent |
| K954006 | YELLOW IRIS URINALYSIS WORKSTATION W/IRISCOPE BODY FLUID ANALYSIS CAPABILITY | Mar 12, 1996 | Substantially Equivalent |
| K943463 | THE YELLOW IRIS | Sep 20, 1994 | Substantially Equivalent |
| K934539 | THE YELLOW IRIS URINALYSIS WORKSTATION WITH IRISCOPE BODY FLUID ANALYSIS CAPABILITY | Mar 30, 1994 | Substantially Equivalent |
| K914256 | YELLOW IRIS URINALYSIS WRKSTA W/IRISCOPE BDY FLU | May 1, 1992 | Substantially Equivalent |
| K874207 | THE PURPLE IRIS(TM) CYTOPATHOLOGY WORKSTATION | Jan 5, 1988 | Substantially Equivalent |