FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICRO21 WITH RETIC
K Number: K960776
·
Decision May 17, 1996
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
34
Applicant Total
6
Review Days
81
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Basic Information
- Device Name
- MICRO21 WITH RETIC
- K Number
- K960776
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5260
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Triangle Biomedical Sciences, Inc.
- Date Received
- February 26, 1996
- Decision Date
- May 17, 1996
- Product Code
- JOY
- 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 |
|---|---|---|---|
| JOY | Device, Automated Cell-Locating | FDA class 2 | Hematology |
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Other Clearances by Triangle Biomedical Sciences, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K982301 | MICRO21 WITH URINE SEDIMENT ANALYSIS | Aug 7, 1998 | Substantially Equivalent |
| K973050 | MICRO21 WITH WBC ESTIMATE | Nov 7, 1997 | Substantially Equivalent |
| K971470 | MICRO21 WITH CEREBROSPINAL FLUID | Sep 16, 1997 | Substantially Equivalent |
| K964165 | MICRO21 WITH NDNA | Jan 3, 1997 | Substantially Equivalent |
| K960774 | MICRO21 WITH ANA | May 22, 1996 | Substantially Equivalent |