Resubmission of the Kleerzit Reagent
FDA 510(k) K864866 · Advanced Biomedical Methods, Inc.
510(k) numberK864866
Submission
- Device name
- Resubmission of the Kleerzit Reagent
- Applicant
- Advanced Biomedical Methods, Inc.
Niles, IL, US - Received
- December 11, 1986
- Decision date
- March 16, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JKA – Tubes, Vials, Systems, Serum Separators, Blood Collection
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1675
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JKA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252899 | Female Culture Device; Male Culture Device; Transfer Device; Access DeviceJKA · Traditional | Zhejiang Kindly Medical Device Co., Ltd. | 06/02/2026SE |
| K260128 | BD Preset and BD A-Line Arterial Blood Collection SyringesJKA · Special | Becton, Dickinson and Company | 04/15/2026SE |
| K252506 | BD Vacutainer® Safety-Lok Blood Collection Set; BD Vacutainer® Safety-Lok Blood…JKA · Traditional | Becton, Dickinson and Company | 04/10/2026SE |
| K252378 | BD® MiniDraw Capillary Blood Collection System with BD® MiniDraw SST Capillary Blood…JKA · Traditional | Becton, Dickinson and Company | 04/10/2026SE |
| K252040 | BD Vacutainer® Plasma Separator Tubes (PST), BD Vacutainer® Sodium Heparin Blood…JKA · Traditional | Becton, Dickinson and Company | 03/13/2026SE |
| K251812 | Steripath® Flow Blood Collection SystemJKA · Traditional | Magnolia Medical Technologies | 09/25/2025SE |
| K243207 | BD Vacutainer® Eclipse Blood Collection NeedleJKA · Traditional | Becton, Dickinson and Company | 07/03/2025SE |
| K250961 | Blood collection tube holdersJKA · Traditional | Promisemed Hangzhou Meditech Co., Ltd. | 06/04/2025SE |
| K244047 | Navi Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG)JKA · Traditional | Venocare, Inc. | 05/23/2025SE |
| K250907 | Sol-Guard TM XtraThin Safety Pull-Button Blood Collection SetJKA · Special | Sol-Millennium Medical, Inc. | 04/30/2025SE |
More from Sol-Millennium Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K945353 | Clarit(Tm)JKA · Traditional | 12/09/1994SE |
| K880949 | Single Reagent Calcium for Demand AnalyzerCJY · Traditional | 04/05/1988SE |
| K852784 | Alkaline PhosphataseCJE · Traditional | 07/22/1985SE |
| K852783 | Sgot/Alt ReagentCIT · Traditional | 07/22/1985SE |
| K852027 | GGTP Reagent/Serum Iron/Salicylate Demand AnalyzerDKJ · Traditional | 05/29/1985SE |
| K850381 | Magnesium Reagent for Demand AnalyzerJGJ · Traditional | 03/01/1985SE |
| K850380 | Inorganic Phosphorous for Demand AnalyzerCEO · Traditional | 03/01/1985SE |
| K850379 | Direct Bilirubin for Demand AnalyzerCIG · Traditional | 03/01/1985SE |
| K850378 | LDH Reagent for Demand AnalyzerCFJ · Traditional | 03/01/1985SE |
| K844332 | Creatinine Reagent for Demand AnalyzerCGX · Traditional | 01/03/1985SE |
Questions and answers
When was Resubmission of the Kleerzit Reagent cleared by the FDA?
Resubmission of the Kleerzit Reagent (K864866) received a 510(k) decision of Substantially Equivalent on March 16, 1987, 95 days after the submission was received.
What is the product code of K864866?
The FDA product code is JKA – Tubes, Vials, Systems, Serum Separators, Blood Collection, a Class II (moderate risk) device regulated under 21 CFR 862.1675.