TIP TOP(R) DISPENSER CAPS
FDA 510(k) clearance K896670 · decided 1990-03-23
Clearance details
- K-number
- K896670
- Device name
- TIP TOP(R) DISPENSER CAPS
- Applicant
- Helena Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1989-11-27
- Decision date
- 1990-03-23
- Days to decision
- 116 days
- Clearance type
- Traditional
- Product code
- GJW
- Device class
- 1
- Regulation number
- 864.6160
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Beaumont, TX, 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 |
|---|---|---|
| PIPETS UNIFORM DROP SIZE BOROSILICATE (K771137) | Dade, Baxter Travenol Diagnostics, Inc. | 1977-08-04 |
| 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.