FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SERIES 9100 PLUS AUTOMATED DIFFERENTIAL HEMATOLOGY ANALYZERS
K Number: K953598
·
Decision Mar 11, 1996
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
379
Applicant Total
25
Review Days
223
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Basic Information
- Device Name
- SERIES 9100 PLUS AUTOMATED DIFFERENTIAL HEMATOLOGY ANALYZERS
- K Number
- K953598
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5220
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Serono Diagnostics, Inc.
- Date Received
- August 1, 1995
- Decision Date
- March 11, 1996
- Product Code
- GKZ
- 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 |
|---|---|---|---|
| GKZ | Counter, Differential Cell | FDA class 2 | Hematology |
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Other Clearances by Serono Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
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| K883085 | T3 UPTAKE SEROZYME ENZYME IMMUNO KT/MAG SOLID PHAS | Sep 9, 1988 | Substantially Equivalent |
| K882340 | LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT,MAG SOL PHA | Aug 8, 1988 | Substantially Equivalent |
| K880388 | T3 SEROZYME ENZYMEIMMUNOASSAY KIT, MAG SOLID PHASE | Mar 3, 1988 | Substantially Equivalent |
| K874866 | T4 SEROZYME ENZYMEIMMUNOASSAY KIT/MAG. SOLID PHASE | Feb 11, 1988 | Substantially Equivalent |
| K873431 | PROGESTERONE MAIA RADIOIMMUNO ASSAY KIT MAG SLD PH | Oct 20, 1987 | Substantially Equivalent |
| K873186 | LH MAIACLONE IMMUNORADIO. ASSAY KIT, MAG SOLID PHA | Sep 29, 1987 | Substantially Equivalent |
| K873400 | PROLACTIN MAIACLONE IMMUNORADIO. KIT, MAG SOL PHA | Sep 25, 1987 | Substantially Equivalent |
| K872862 | PRL SEROZYME IMMUNOENZ. ASSAY KIT, MAG. SOLID PHAS | Sep 18, 1987 | Substantially Equivalent |
| K873033 | HCG SEROZYME IMMUNOENZYM ASSAY KIT/MAG SOLID PHASE | Sep 14, 1987 | Substantially Equivalent |