510(k) K771138
- Device
- PIPETS BOROSILICATE GLASS
- Applicant
- Dade, Baxter Travenol Diagnostics, Inc.
- 510(k) number
- K771138
- Product code
- GJW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-08-04
- Date received
- 1977-06-24
- Regulation
- 864.6160
- Classification name
- Pipette, Pasteur
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3015505238
- 3034669683
- 3009155756
- 3013530901
- 3005621808
- 3030519472
- 2244900
- 3018779125
- 3034205711
- 3019387954
- 3013894805
- 3016758972
- 3005941719
- 1063851
- 3044466317
- 3017178434
- 3017955445
- 3010420046
- 3008496560
- 3006897996
- 3031184338
- 3021013122
- 3010194621
- 3011676045
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GJW#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K896670 | TIP TOP(R) DISPENSER CAPS | Helena Laboratories | 1990-03-23 |
| K771137 | PIPETS UNIFORM DROP SIZE BOROSILICATE | Dade, Baxter Travenol Diagnostics, Inc. | 1977-08-04 |
| K760899 | STERILE DISPOSABLE COTTON PLUGGED SER. | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1976-11-09 |