ACUSYST-P (CELL CULTURE EQUIPMENT)
FDA 510(k) clearance K864334 · decided 1986-11-24
Clearance details
- K-number
- K864334
- Device name
- ACUSYST-P (CELL CULTURE EQUIPMENT)
- Applicant
- Endotronics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-11-04
- Decision date
- 1986-11-24
- Days to decision
- 20 days
- Clearance type
- Traditional
- Product code
- KJH
- Device class
- 1
- Regulation number
- 864.2240
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Coon Rapids, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ACUSYST-P/3X (K875151) | Endotronics, Inc. | 1988-01-12 |
| ACUSYST-JR (K872086) | Endotronics, Inc. | 1987-06-15 |
Recalls involving this device
No recalls on record reference this clearance.