510(k) K841307
- Device
- Bbl Gaspak Pouch
- Applicant
- BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
- 510(k) number
- K841307
- Product code
- FKJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-05-14
- Date received
- 1984-03-30
- Regulation
- 876.5820
- Classification name
- Filter, Blood, Dialysis
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 1875 Eye St. NW Suite 625 Washington DC US 20006 20006
FDA Registration Numbers#
- 1833387
- 2028411
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FKJ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253863 | GUARDIAN™ Quick Dip Residual Chlorine (5212) | Serim Research | 2026-03-17 |
| K901734 | SERIM RESIDUAL CHLORINE TEST KIT | Serim Research Corp. | 1990-09-13 |
| K820575 | J.E.T. DIALYSIS SYSTEM | Computer Dialysis Systems, Inc. | 1982-05-20 |
| K772040 | TRANSDUCER PROTECTOR | Terumo America, Inc. | 1977-11-28 |