Albumin Reagent
FDA 510(k) K890333 · Alpkem Corp.
510(k) numberK890333
Submission
- Device name
- Albumin Reagent
- Applicant
- Alpkem Corp.
Clackamas, OR, US - Received
- January 23, 1989
- Decision date
- February 17, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EIX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K960245 | Vip Victor Interactive ProbeEIX · Traditional | Pro-Dentec | 04/04/1996SE |
| K944848 | The Vivacare T.P.S. ProbeEIX · Traditional | Rms Div. | 12/14/1994SE |
| K936221 | Probe Tip/Peri Probe/Peri Probe Comp.EIX · Traditional | Pd International AB | 08/01/1994SE |
| K880827 | Accutek Periodontal ProbeEIX · Traditional | Sweet Micro Systems, Inc. | 04/12/1988SE |
| K875076 | Florida ProbeEIX · Traditional | Florida Probe Corp. | 03/10/1988SE |
| K870280 | Accudent AccuprobeEIX · Traditional | Accudent, Inc. | 06/08/1987SE |
| K871504 | Disposable Periodontal ProbeEIX · Traditional | Periodontal Health Brush, Inc. | 05/06/1987SE |
| K823324 | Dental Instruments - ProbesEIX · Traditional | Miltex, Inc. | 11/24/1982SE |
More from Miltex, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K894011 | Total GalactoseKQP · Traditional | 01/11/1990SE |
| K891070 | Phenylalanine (Ninhydrin Reaction)JNB · Traditional | 10/27/1989SE |
| K890334 | Total Cholesterol ReagentCHH · Traditional | 05/03/1989SE |
| K890337 | Triglycerides - Gpo ReagentCDT · Traditional | 03/09/1989SE |
| K890336 | Glucose (God) ReagentCGA · Traditional | 02/27/1989SE |
| K890335 | Sodium Hydroxide Solution, Creatinine Reag./Dilu.CGE · Traditional | 02/17/1989SE |
| K890332 | RFA/2 Rapid Flow Analyzer W/ComputerJJC · Traditional | 02/17/1989SE |
| K883020 | RFA-300 Rapid Flow Analyzer W/ComputerJJF · Traditional | 09/02/1988SE |
| K860367 | Magnesium (Substrate, Enzyme, Reagent)JGF · Traditional | 04/11/1986SE |
| K852005 | MG ReagentJGJ · Traditional | 06/25/1985SE |
Questions and answers
When was Albumin Reagent cleared by the FDA?
Albumin Reagent (K890333) received a 510(k) decision of Substantially Equivalent on February 17, 1989, 25 days after the submission was received.
What is the product code of K890333?
The FDA product code is EIX – Probe, Periodontic, a Class I (low risk) device regulated under 21 CFR 872.4565.