FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEMATOLOGY CONTROL MIXTURES FOR QUALITY CONTROL
K Number: K893895
·
Decision Jul 25, 1989
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
191
Applicant Total
5
Review Days
56
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Basic Information
- Device Name
- HEMATOLOGY CONTROL MIXTURES FOR QUALITY CONTROL
- K Number
- K893895
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.8625
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Intercare Diagnostics, Inc.
- Date Received
- May 30, 1989
- Decision Date
- July 25, 1989
- Product Code
- JPK
- 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 |
|---|---|---|---|
| JPK | Mixture, Hematology Quality Control | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JPK), ordered by most recent decision date.
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Other Clearances by Intercare Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K941938 | THE MIRAGE SYSTEM BIOFEEDBACK INTERFACE | Aug 5, 1994 | Substantially Equivalent |
| K920569 | INDXTM DIP-S-TICKSTM | Feb 9, 1993 | Substantially Equivalent |
| K901597 | INDX DIP S TICKS | Dec 21, 1990 | Substantially Equivalent |
| K862948 | CHLAMYDIA TISSUE CULTURE CONFIRMATION TEST (EIA) | Oct 17, 1986 | Substantially Equivalent |