SOLOPAK PHARMACEUTICALS INC. STERILE EMPTY VIAL
FDA 510(k) clearance K950822 · decided 1995-03-22
Clearance details
- K-number
- K950822
- Device name
- SOLOPAK PHARMACEUTICALS INC. STERILE EMPTY VIAL
- Applicant
- Solopak Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-02-22
- Decision date
- 1995-03-22
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- LDH
- Advisory committee
- Unknown
- Location
- Elk Grove Village, IL, 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 |
|---|---|---|
| STERILE EMPTY GLASS VIALS (K883686) | Farris Laboratories, Inc. | 1988-09-23 |
| STERILE EMPTY VIALS (K875227) | Allertech, Inc. | 1988-03-04 |
Recalls involving this device
No recalls on record reference this clearance.