Alb BCG Reagent
FDA 510(k) K852007 · Alpkem Corp.
510(k) numberK852007
Submission
- Device name
- Alb BCG Reagent
- Applicant
- Alpkem Corp.
Clackamas, OR, US - Received
- May 7, 1985
- Decision date
- May 30, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CIX – Bromcresol Green Dye-Binding, Albumin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1035
- Specialty
- Clinical Chemistry
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| K251157 | Core MetabolicCIX · Traditional | Truvian Health | 01/09/2026SE |
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| K170901 | Albumin, Alkaline Phosphatase (Alp)-Amp, Glucose-Hexokinase, BA400CIX · Traditional | Biosystems S.A. | 04/13/2018SE |
| K131488 | Ace Albumin Reagent, Ace Total Protein Reagent, Ace Calcium-Arsenazo Reagent and Ace…CIX · Traditional | Alfa Wassermann Diagnostics Technologies, LLC | 08/19/2013SE |
| K113374 | Ace Albumin Reagent Ace Total Protein Reagent Ace Calcium-Arsenazo Reagent Ace…CIX · Traditional | Alfa Wassermann Diagnostic Technologies, Inc. | 07/13/2012SE |
| K110818 | Poly-Chem 90 Albumin, Bun, Calcium, Carbon Dioxide, Creatinine, and Total Protein TestsCIX · Traditional | Polymedco, Inc. | 09/08/2011SE |
| K110830 | Elitech Clinical Systems Calcium Arsenazo; Elitech Clinical Systems Albumin; Elitech…CIX · Traditional | Elitechgroup | 06/21/2011SE |
| K101088 | Easyra Albumin, Calcium, Magnesium and Inorganic Phosphorous ReagentCIX · Traditional | Medica Corp. | 04/04/2011SE |
More from Medica Corp.
| 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 |
| K890333 | Albumin ReagentEIX · 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 |
Questions and answers
When was Alb BCG Reagent cleared by the FDA?
Alb BCG Reagent (K852007) received a 510(k) decision of Substantially Equivalent on May 30, 1985, 23 days after the submission was received.
What is the product code of K852007?
The FDA product code is CIX – Bromcresol Green Dye-Binding, Albumin, a Class II (moderate risk) device regulated under 21 CFR 862.1035.