STERILE EMPTY VIALS
FDA 510(k) clearance K875227 · decided 1988-03-04
Clearance details
- K-number
- K875227
- Device name
- STERILE EMPTY VIALS
- Applicant
- Allertech, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-12-22
- Decision date
- 1988-03-04
- Days to decision
- 73 days
- Clearance type
- Traditional
- Product code
- LDH
- Advisory committee
- Unknown
- Location
- Littleton, CO, 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 |
|---|---|---|
| SOLOPAK PHARMACEUTICALS INC. STERILE EMPTY VIAL (K950822) | Solopak Laboratories, Inc. | 1995-03-22 |
| STERILE EMPTY GLASS VIALS (K883686) | Farris Laboratories, Inc. | 1988-09-23 |
Recalls involving this device
No recalls on record reference this clearance.