FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TOXOPLASMA IGM CLIN-ELISA(TM) CAT # 5560
K Number: K874594
·
Decision Mar 7, 1988
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
105
Applicant Total
30
Review Days
119
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Basic Information
- Device Name
- TOXOPLASMA IGM CLIN-ELISA(TM) CAT # 5560
- K Number
- K874594
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3780
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Clinical Sciences, Inc.
- Date Received
- November 9, 1987
- Decision Date
- March 7, 1988
- Product Code
- LGD
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | FDA class 2 | Microbiology |
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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 |
| 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 |
| K854666 | CYTOMEGALOVIRUS (CMV) ELISA TEST SYS. CAT. NO:4530 | Feb 5, 1986 | Substantially Equivalent |