PRE-CALIBRATED PIPETTES
FDA 510(k) clearance K834100 · decided 1984-02-21
Clearance details
- K-number
- K834100
- Device name
- PRE-CALIBRATED PIPETTES
- Applicant
- Vitex
- Decision
- Substantially Equivalent
- Date received
- 1983-11-30
- Decision date
- 1984-02-21
- Days to decision
- 83 days
- Clearance type
- Traditional
- Product code
- JRC
- Device class
- 1
- Regulation number
- 862.2050
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- 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 |
|---|---|---|
| SMI DIGITRON (K840186) | Scientific Manufacturing Industries | 1984-04-05 |
| DADE DISP. DISPENSING-SPREADING PIPETS (K822078) | American Dade | 1982-07-27 |
| MICROPITETTE (K792696) | Meridian Diagnostics, Inc. | 1980-02-01 |
| LABORATORY EXPENDABLE PRODUCTS (K770594) | Abco Dealers, Inc. | 1977-07-06 |
| LANCER PLASTIC TRANSFER PIPETTE (K760621) | Sherwood Medical Industries | 1976-10-05 |
Recalls involving this device
No recalls on record reference this clearance.