BARIUM SULFATE, USP IN SUSPENSION
FDA 510(k) clearance K800459 · decided 1980-05-30
Clearance details
- K-number
- K800459
- Device name
- BARIUM SULFATE, USP IN SUSPENSION
- Applicant
- Central Pharmaceuticals, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-02-29
- Decision date
- 1980-05-30
- Days to decision
- 91 days
- Clearance type
- Traditional
- Product code
- KTA
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Central Pharmaceuticals
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MEDEFIZZ A & MEDEFIZZ B (K800843) | Medefield Pty. , Ltd. | 1980-06-17 |
| MEDEFOAM-2 (K800840) | Medefield Pty. , Ltd. | 1980-06-17 |
| MEDEBAR M (K800841) | Medefield Pty. , Ltd. | 1980-05-30 |
| MEDEBAR XAC-90 (K800842) | Medefield Pty. , Ltd. | 1980-05-30 |
| MEDESCAN (K800839) | Medefield Pty. , Ltd. | 1980-05-30 |
| MEDEBAR XL (K800844) | Medefield Pty. , Ltd. | 1980-05-30 |
| BARIMEX, BARIUM SULFATE COMPOUND (K760736) | C.R. Bard, Inc. | 1976-11-09 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| CENTRAL'S PHARM. SALT TABLETS FOR DISINFECTION (P810030/S001) | Central Pharmaceuticals, Inc. | 1985-08-22 |