FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SKIN GRAFT PRESERVATION MEDIUM (TISSUE)
K Number: K870451
·
Decision May 26, 1987
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
366
Applicant Total
6
Review Days
112
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Basic Information
- Device Name
- SKIN GRAFT PRESERVATION MEDIUM (TISSUE)
- K Number
- K870451
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.2220
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Bioclinical Laboratory Services, Inc.
- Date Received
- February 3, 1987
- Decision Date
- May 26, 1987
- 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 Bioclinical Laboratory Services, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K870250 | MODIFIED MCCAREY-KAUFMAN CORNEAL STORAGE MEDIUM | Apr 6, 1987 | Substantially Equivalent |
| K870251 | CHONDROITIN SULFATE CORNEAL STORAGE MEDIUM | Apr 6, 1987 | Substantially Equivalent |
| K870249 | MCCAREY-KAUFMAN CORNEAL STORAGE MEDIUM | Apr 6, 1987 | Substantially Equivalent |
| K864396 | LYMPHOCYTE MAINTENANCE MEDIUM | Feb 2, 1987 | Substantially Equivalent |
| K864740 | BONE MARROW COLLECTION MEDIUM | Jan 5, 1987 | Substantially Equivalent |