IMMU-SAL IMMUNOHEMATOLOGICAL SALINE
FDA 510(k) clearance K761303 · decided 1976-12-30
Clearance details
- K-number
- K761303
- Device name
- IMMU-SAL IMMUNOHEMATOLOGICAL SALINE
- Applicant
- Dade, Baxter Travenol Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1976-12-22
- Decision date
- 1976-12-30
- Days to decision
- 8 days
- Clearance type
- Traditional
- Product code
- KSS
- Device class
- 1
- Regulation number
- 864.9050
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Mchenry, 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 |
|---|---|---|
| FLUID SAMPLING PACK (K874436) | U.S. Mfg. & Management, Inc. | 1988-01-05 |
| S/P SERUM DROPPER PIPETS (K812892) | American Dade | 1981-10-27 |
| PRE-DENT SYSTEM OR PRE-DENT II (K801386) | Pre-Dent System | 1980-07-14 |
| PRE-DENT SYSTEM MODIFIED (K801516) | Pre-Dent System | 1980-07-14 |
| PRE-DENT SYSTEM (K800736) | Pre-Dent System | 1980-04-24 |
Recalls involving this device
No recalls on record reference this clearance.