FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
B-HCG HUMAN SERUM CONTROLS
K Number: K932479
·
Decision Dec 2, 1993
Classifications
1
FEI Numbers
269
Registration Numbers
269
Same Product Code
492
Applicant Total
12
Review Days
192
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Basic Information
- Device Name
- B-HCG HUMAN SERUM CONTROLS
- K Number
- K932479
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Pyramid Biological Corp.
- Date Received
- May 24, 1993
- Decision Date
- December 2, 1993
- Product Code
- JJX
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | FDA class 1 | Clinical Chemistry |
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| 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 |
| K951800 | CMV IGG HUMAN SERUM CONTROLS | Nov 16, 1995 | Substantially Equivalent |
| K952254 | ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS | Nov 16, 1995 | Substantially Equivalent |
| K944515 | SERUM PROTEIN CONTROLS | Nov 17, 1994 | Substantially Equivalent |