FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NDNA IMMUNOPATH FLUORO-KIT
K Number: K770057
·
Decision Apr 5, 1977
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
109
Applicant Total
30
Review Days
84
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Basic Information
- Device Name
- NDNA IMMUNOPATH FLUORO-KIT
- K Number
- K770057
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Clinical Sciences, Inc.
- Date Received
- January 11, 1977
- Decision Date
- April 5, 1977
- Product Code
- DHN
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | FDA class 2 | Immunology |
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Other Clearances by Clinical Sciences, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K900688 | VARICELLA ZOSTER IGG CLIN-ELISA TEST KIT | May 15, 1990 | Substantially Equivalent |
| K883870 | EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGG #4590 | Jul 14, 1989 | Substantially Equivalent |
| K883871 | EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGM #5590 | Jul 14, 1989 | Substantially Equivalent |
| K891990 | RUBEOLA IGG CLIN-ELISA TEST SYSTEM, CAT. #4600 | Jun 15, 1989 | Substantially Equivalent |
| K883600 | EPSTEIN-BARR VIRUS (EBNA-1) IGG CATA. #4550 | May 11, 1989 | Substantially Equivalent |
| K883601 | EPSTEIN-BARR VIRUS (EBNA-1) IGM CATA. #5550 | May 11, 1989 | Substantially Equivalent |
| K874594 | TOXOPLASMA IGM CLIN-ELISA(TM) CAT # 5560 | Mar 7, 1988 | Substantially Equivalent |
| K872942 | IGM CMV CLIN-ELISA(TM) TEST SYSTEM NUMBER: 5530 | Jan 11, 1988 | Substantially Equivalent |
| K860145 | RUBELLA ELISA TEST SYSTEM CATALOG NUMBER: 4540 | Jul 14, 1986 | Substantially Equivalent |
| K860773 | TOXOPLASMA IGG CLIN-ELISA TEST KIT CAT. NO. 4560 | May 23, 1986 | Substantially Equivalent |