DISPOSABLE CONTROLLED DROP PASTEUR PIPET
FDA 510(k) clearance K780237 · decided 1978-03-09
Clearance details
- K-number
- K780237
- Device name
- DISPOSABLE CONTROLLED DROP PASTEUR PIPET
- Applicant
- Owens-Illinois, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-02-13
- Decision date
- 1978-03-09
- Days to decision
- 24 days
- Clearance type
- Traditional
- Product code
- GJG
- Device class
- 1
- Regulation number
- 864.6160
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- El Paso, 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 |
|---|---|---|
| LIQUIPETTE (K831079) | The Kendall Company Div. of Tyco Healthcare Group | 1983-04-28 |
| PIPETTES, PLASTIC DISPOSABLE (K781891) | Hillwood Corp. | 1978-11-15 |
| UNIFORM DROP SIZE PASTEUR TYPE PIPETS (K760719) | Dade, Baxter Travenol Diagnostics, Inc. | 1976-10-29 |
Recalls involving this device
No recalls on record reference this clearance.