PIPETS UNIFORM DROP SIZE BOROSILICATE
FDA 510(k) clearance K771137 · decided 1977-08-04
Clearance details
- K-number
- K771137
- Device name
- PIPETS UNIFORM DROP SIZE BOROSILICATE
- Applicant
- Dade, Baxter Travenol Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1977-06-24
- Decision date
- 1977-08-04
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- GJW
- Device class
- 1
- Regulation number
- 864.6160
- 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 |
|---|---|---|
| TIP TOP(R) DISPENSER CAPS (K896670) | Helena Laboratories | 1990-03-23 |
| PIPETS BOROSILICATE GLASS (K771138) | Dade, Baxter Travenol Diagnostics, Inc. | 1977-08-04 |
| STERILE DISPOSABLE COTTON PLUGGED SER. (K760899) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1976-11-09 |
Recalls involving this device
No recalls on record reference this clearance.