FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ALPHACALF SERUM
K Number: K884654
·
Decision Nov 30, 1988
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
366
Applicant Total
11
Review Days
23
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Basic Information
- Device Name
- ALPHACALF SERUM
- K Number
- K884654
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.2220
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Hyclone Laboratories, Inc.
- Date Received
- November 7, 1988
- Decision Date
- November 30, 1988
- 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 Hyclone Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K880471 | BOVINE CALF SERUM SUPPLEMENTED #A-2159 | Apr 4, 1988 | Substantially Equivalent |
| K880470 | BOVINE CALF SERUM CATALOG #A-2119 | Apr 1, 1988 | Substantially Equivalent |
| K870938 | FETAL BOVINE SERUM | Mar 31, 1987 | Substantially Equivalent |
| K870467 | DEFINED CALF BOVINE SERUM SUPPLEMENTED #A-2151 | Mar 24, 1987 | Substantially Equivalent |
| K870469 | DEFINED EQUINE SERUM #A-3311 | Mar 24, 1987 | Substantially Equivalent |
| K870464 | CHARACTERIZED FETAL BOVINE SERUM #A-1115 | Mar 24, 1987 | Substantially Equivalent |
| K870466 | DEFINED CALF BOVINE SERUM #A-2111 | Mar 24, 1987 | Substantially Equivalent |
| K870463 | DEFINED FETAL BOVINE SERUM #A-1111 | Mar 24, 1987 | Substantially Equivalent |
| K870468 | ADULT BOVINE SERUM | Mar 24, 1987 | Substantially Equivalent |
| K870465 | 6/40 FETAL BOVINE SERUM #A-1110 | Mar 24, 1987 | Substantially Equivalent |