FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
CHONDROITIN SULFATE CORNEAL STORAGE MEDIUM
K Number: K870251
·
Decision Apr 6, 1987
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
19
Applicant Total
6
Review Days
75
Basic Information
- Device Name
- CHONDROITIN SULFATE CORNEAL STORAGE MEDIUM
- K Number
- K870251
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- BIOCLINICAL LABORATORY SERVICES, INC.
- Date Received
- January 21, 1987
- Decision Date
- April 6, 1987
- Product Code
- LYX
- Advisory Committee
- Unknown
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| LYX | Media, Corneal Storage | FDA unclassified | Unknown |
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Other Clearances by BIOCLINICAL LABORATORY SERVICES, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K870451 | SKIN GRAFT PRESERVATION MEDIUM (TISSUE) | May 26, 1987 | Substantially Equivalent |
| K870249 | MCCAREY-KAUFMAN CORNEAL STORAGE MEDIUM | Apr 6, 1987 | Substantially Equivalent |
| K870250 | MODIFIED 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 |