FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CELL CULTURE REFEED MEDIUM
K Number: K850537
·
Decision Mar 20, 1985
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
366
Applicant Total
33
Review Days
37
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Basic Information
- Device Name
- CELL CULTURE REFEED MEDIUM
- K Number
- K850537
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.2220
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Hillcrest Biologicals
- Date Received
- February 11, 1985
- Decision Date
- March 20, 1985
- Product Code
- KIT
- Advisory Committee
- Hematology
- Review Advisory Committee
- PA
- 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 |
|---|---|---|---|
| KIT | Media And Components, Synthetic Cell And Tissue Culture | FDA class 1 | Hematology |
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Other Clearances by Hillcrest Biologicals
| K Number | Device Name | ||
|---|---|---|---|
| K913618 | ARBOVIRUS IGM IFA TEST | Dec 3, 1992 | Substantially Equivalent |
| K913617 | ARBOVIRUS IGG IFA TEST | Dec 3, 1992 | Substantially Equivalent |
| K913906 | Q FEVER IGG IFA TEST | Oct 21, 1992 | Substantially Equivalent |
| K922374 | Q FEVER IGM IFA TEST | Oct 21, 1992 | Substantially Equivalent |
| K900206 | LYME DISEASE IGM ELISA | Jun 28, 1991 | Substantially Equivalent |
| K896594 | EBV VCA ANTIBODY (IGM) | Jan 16, 1990 | Substantially Equivalent |
| K884829 | EBV EARLY ANTIGEN (R+D) | Apr 12, 1989 | Substantially Equivalent |
| K883767 | LYME DISEASE IFA (IGM) | Mar 15, 1989 | Substantially Equivalent |
| K884591 | EBV-VCA ANTIBODY (IGG) | Jan 24, 1989 | Substantially Equivalent |
| K883487 | LYME DISEASE IFA (IGG) | Dec 13, 1988 | Substantially Equivalent |