FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SYPHILIS IGG HUMAN SERUM CONTROLS
K Number: K960493
·
Decision Jun 17, 1996
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
34
Applicant Total
12
Review Days
137
Basic Information
- Device Name
- SYPHILIS IGG HUMAN SERUM CONTROLS
- K Number
- K960493
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3830
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- PYRAMID BIOLOGICAL CORP.
- Date Received
- February 1, 1996
- Decision Date
- June 17, 1996
- Product Code
- LIP
- 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 |
|---|---|---|---|
| LIP | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum | FDA class 2 | Microbiology |
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Other Clearances by PYRAMID BIOLOGICAL CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K964675 | H.PYLORI CONTROLS | Jan 27, 1997 | Substantially Equivalent |
| K962399 | HEPATITIS NEGATIVE CONTROL | Aug 2, 1996 | Substantially Equivalent |
| K961317 | SYPHILIS IGM HUMAN SERUM CONTROLS | Jun 24, 1996 | Substantially Equivalent |
| K954515 | ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA | Dec 20, 1995 | Substantially Equivalent |
| K953826 | ENZYME LINKED UMMINOABSORBENT ASSAY, RUBELLA | Dec 14, 1995 | Substantially Equivalent |
| K952818 | ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII | Nov 20, 1995 | Substantially Equivalent |
| K952254 | ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS | Nov 16, 1995 | Substantially Equivalent |
| K951800 | CMV IGG HUMAN SERUM CONTROLS | Nov 16, 1995 | Substantially Equivalent |
| K944515 | SERUM PROTEIN CONTROLS | Nov 17, 1994 | Substantially Equivalent |
| K933218 | REFRACTOMETRIC, TOTAL PROTEIN | Feb 17, 1994 | Substantially Equivalent |