FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ORTHO ANTISERA CONTROL
K Number: K800310
·
Decision Mar 5, 1980
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
11
Applicant Total
24
Review Days
22
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Basic Information
- Device Name
- ORTHO ANTISERA CONTROL
- K Number
- K800310
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.9650
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Ortho Diagnostics, Inc.
- Date Received
- February 12, 1980
- Decision Date
- March 5, 1980
- Product Code
- KSF
- 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 |
|---|---|---|---|
| KSF | Kit, Quality Control For Blood Banking Reagents | FDA class 2 | Hematology |
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RST-SERIES CONTROL
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TEST CELLS
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Other Clearances by Ortho Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K802404 | ORTHO BOVINE ALBUMIN SOLUTION 30% PROTE | Oct 23, 1980 | Substantially Equivalent |
| K801507 | ANTIGEN CONTROL CELLS | Aug 20, 1980 | Substantially Equivalent |
| K800357 | BI-LEVEL ASSAYED CARD. DRUG CONT., I,II | Apr 16, 1980 | Substantially Equivalent |
| K791791 | ORTHO ANTIBODY ENHANCEMENT SOLUTION | Oct 11, 1979 | Substantially Equivalent |
| K791301 | ORTHO TSH RIA KIT | Sep 24, 1979 | Substantially Equivalent |
| K790813 | MULTECON BLOOD GAS CONTROL | Jun 28, 1979 | Substantially Equivalent |
| K782063 | PREGNANCY, SENSIDEX TUBE TEST | Apr 4, 1979 | Substantially Equivalent |
| K782166 | SLIDE TEST FOR PREGNANCY, GRAVINDEX 90 | Apr 4, 1979 | Substantially Equivalent |
| K781638 | RUBINDEX*DIRECT SYSTEM | Dec 20, 1978 | Substantially Equivalent |
| K781860 | ASSAY, CHROMOGENIC ANTITHROMBIN III | Dec 4, 1978 | Substantially Equivalent |