FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ULTRACLONE ECL-01-900 CELL LINE
K Number: K843862
·
Decision Oct 17, 1984
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
366
Applicant Total
21
Review Days
15
Basic Information
- Device Name
- ULTRACLONE ECL-01-900 CELL LINE
- K Number
- K843862
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.2220
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- EARL-CLAY LABORATORIES, INC.
- Date Received
- October 2, 1984
- Decision Date
- October 17, 1984
- 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 EARL-CLAY LABORATORIES, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K861585 | ULTRACLONE 01-2300 CELL LINE | May 13, 1986 | Substantially Equivalent |
| K861569 | ULTRACLONE 01-700 CELL LINE | May 5, 1986 | Substantially Equivalent |
| K854206 | ULTRACLONE 05-100 GUINEA PIG RBC | Oct 31, 1985 | Substantially Equivalent |
| K853203 | ULTRACLONE ECL-01-2200 CELL LINE | Aug 12, 1985 | Substantially Equivalent |
| K851545 | ULTRACLONE ECL-01-800 CELL LINE | May 10, 1985 | Substantially Equivalent |
| K843578 | ULTRACLONE ECL-01-2100 CELL LINE | Oct 31, 1984 | Substantially Equivalent |
| K843577 | ULTRAXLONE ECL-01-1000 CELL LINE | Oct 31, 1984 | Substantially Equivalent |
| K843579 | ULTRACLONE ECL-01-1100 | Oct 31, 1984 | Substantially Equivalent |
| K843863 | ULTRACLONE ECL-01-1300 CELL LINE | Oct 17, 1984 | Substantially Equivalent |
| K843864 | ULTRACLONE ECL-01-1400 CELL LINE | Oct 17, 1984 | Substantially Equivalent |