510(k) K922342
- Device
- TRI-TECH INC. CUSTOM BLOOD ALCOHOL
- Applicant
- TRI-TECH, INC.
- 510(k) number
- K922342
- Product code
- JKA
- Decision
- Substantially Equivalent - Kit With Drugs (SEKD)
- Decision date
- 1993-08-27
- Date received
- 1992-05-19
- Regulation
- 862.1675
- Classification name
- Tubes, Vials, Systems, Serum Separators, Blood Collection
- Medical specialty
- Clinical Chemistry
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- WENDIE WALKER
- Address
- 5108 Revere Rd. Durham NC US 27713 27713
FDA Registration Numbers#
- 3012598266
- 3008717264
- 3004597845
- 3004425647
- 3030626857
- 3013221738
- 1647137
- 2018685
- 9680794
- 3007616112
- 3018507299
- 1911916
- 3001452053
- 3009963993
- 3006850222
- 8021538
- 1915484
- 3024537844
- 1060680
- 3020294761
- 3012307300
- 3017210488
- 3002807968
- 2434982
- 1219611
- 2321034
- 9617475
- 3010131137
- 9610847
- 9611446
- 3012536737
- 3015453963
- 1054811
- 3008449424
- 2030624
- 3026940910
- 3022147580
- 3016884191
- 3033589330
- 8010026
- 1058602
- 3016844398
- 3002807408
- 3010220595
- 3001124136
- 2320762
- 1054241
- 3028019212
- 3013652330
- 3020831613
- 8041187
- 1917413
- 3008272066
- 3017509841
- 3029901632
- 1710034
- 3004416208
- 3003120666
- 2032521
- 3008307705
- 3013513377
- 3013187142
- 3002682307
- 9615588
- 3034667025
- 3014570560
- 9681572
- 2245437
- 1036836
- 3015309643
- 3022964615
- 3013248161
- 3043226252
- 1319639
- 1531062
- 2024311
- 3010419931
- 3015620563
- 9613662
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JKA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260128 | BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes | Becton, Dickinson and Company | 2026-04-15 |
| K252506 | BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached Holder | Becton, Dickinson and Company | 2026-04-10 |
| K252378 | BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection Tube | Becton, Dickinson and Company | 2026-04-10 |
| K252040 | BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection Tubes | Becton, Dickinson and Company | 2026-03-13 |
| K251812 | Steripath® Flow™ Blood Collection System | Magnolia Medical Technologies | 2025-09-25 |
| K243207 | BD Vacutainer® Eclipse™ Blood Collection Needle | Becton, Dickinson and Company | 2025-07-03 |
| K250961 | Blood collection tube holders | Promisemed Hangzhou Meditech Co., Ltd. | 2025-06-04 |
| K244047 | Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG) | Venocare, Inc. | 2025-05-23 |
| K250907 | Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set | Sol-Millennium Medical, Inc. | 2025-04-30 |
| K243649 | BD Vacutainer® Multiple Sample Luer Adapter | Becton, Dickinson and Company | 2025-03-21 |
| K241586 | PIVO™ Pro Needle-free Blood Collection Device | Becton Dickinson Infusion Therapy Systems, Inc. | 2025-02-27 |
| K242320 | BD Vacutainer® One Use Holder | Becton, Dickinson and Company | 2024-11-01 |
| K233979 | VACUETTE® QUICKSHIELD Complete (Plus) | Greiner Bio-One North America, Inc. | 2024-07-19 |
| K232781 | Safety Sliding Blood Collection Set | Jiangsu Caina Medical Co.,Ltd | 2024-03-07 |
| K231373 | BD Vacutainer® K2 EDTA Blood Collection Tubes | Becton, Dickinson and Company | 2024-02-02 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases