FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QUICK-COUNT HEMATOLOGY CONTROLS
K Number: K851663
·
Decision Jul 23, 1985
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
191
Applicant Total
20
Review Days
91
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Basic Information
- Device Name
- QUICK-COUNT HEMATOLOGY CONTROLS
- K Number
- K851663
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.8625
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Seragen Diagnostics, Inc.
- Date Received
- April 23, 1985
- Decision Date
- July 23, 1985
- 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 |
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Other Clearances by Seragen Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K872148 | VIVID CHLAMYDIA(TM) | Aug 19, 1987 | Substantially Equivalent |
| K852260 | QUICK-CHEM CALIBRATION SET | Jul 22, 1985 | Substantially Equivalent |
| K851520 | CK/LD ISOENZYMES CONTROLS(HUMAN) | Jun 25, 1985 | Substantially Equivalent |
| K851521 | LD-1(IMMUNO) SEPARATION SET | May 10, 1985 | Substantially Equivalent |
| K850209 | QUICK-LYTE | Feb 27, 1985 | Substantially Equivalent |
| K844743 | SERATEST ENA(RNP/SM) DETERMINATION | Feb 4, 1985 | Substantially Equivalent |
| K842563 | SERATEST DNA DETERMINATION | Oct 25, 1984 | Substantially Equivalent |
| K841504 | QUICK-COUNT PLUS 2 | Jun 11, 1984 | Substantially Equivalent |
| K840793 | CK/MB IMMUNO-ISOENZYME CONTROL SERUM | Apr 13, 1984 | Substantially Equivalent |
| K840863 | SERATEST RF LATEX DETERMINATION | Apr 4, 1984 | Substantially Equivalent |