FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ULTRACLONE 05-100 GUINEA PIG RBC
K Number: K854206
·
Decision Oct 31, 1985
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
122
Applicant Total
21
Review Days
15
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Basic Information
- Device Name
- ULTRACLONE 05-100 GUINEA PIG RBC
- K Number
- K854206
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Earl-Clay Laboratories, Inc.
- Date Received
- October 16, 1985
- Decision Date
- October 31, 1985
- Product Code
- KPO
- Advisory Committee
- Gastroenterology, Urology
- 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 |
|---|---|---|---|
| KPO | Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | FDA class 2 | Gastroenterology, Urology |
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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 |
| K853203 | ULTRACLONE ECL-01-2200 CELL LINE | Aug 12, 1985 | Substantially Equivalent |
| K851545 | ULTRACLONE ECL-01-800 CELL LINE | May 10, 1985 | Substantially Equivalent |
| K843577 | ULTRAXLONE ECL-01-1000 CELL LINE | Oct 31, 1984 | Substantially Equivalent |
| K843578 | ULTRACLONE ECL-01-2100 CELL LINE | Oct 31, 1984 | Substantially Equivalent |
| K843579 | ULTRACLONE ECL-01-1100 | Oct 31, 1984 | Substantially Equivalent |
| K843862 | ULTRACLONE ECL-01-900 CELL LINE | Oct 17, 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 |