Biotrol Chloride
FDA 510(k) K890015 · Biotrol, USA, Inc.
510(k) numberK890015
Submission
- Device name
- Biotrol Chloride
- Applicant
- Biotrol, USA, Inc.
Westchester, PA, US - Received
- January 3, 1989
- Decision date
- February 17, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CHJ – Mercuric Thiocyanate, Colorimetry, Chloride
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1170
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CHJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K010670 | Piccolo Chloride Test SystemCHJ · Traditional | Abaxis, Inc. | 04/26/2001SE |
| K945408 | 340-CHLORIDE for Discrete Random Access AnalyzerCHJ · Traditional | Catachem, Inc. | 02/22/1995SE |
| K943006 | Chloride QvetCHJ · Traditional | Prisma Systems | 12/07/1994SE |
| K934136 | Olympus Chloride Reagent, ModificationCHJ · Traditional | Olympus Corp. | 11/05/1993SE |
| K932528 | Olympus Chlorid Reagent, ModifiedCHJ · Traditional | Olympus Corp. | 09/17/1993SE |
| K925338 | Olympus Chloride ReagentCHJ · Traditional | Olympus Corp. | 12/11/1992SE |
| K922921 | King Diagnostics Chloride ReagentCHJ · Traditional | King Diagnostics, Inc. | 10/05/1992SE |
| K923610 | Olympus Chloride ReagentCHJ · Traditional | Olympus Corp. | 10/02/1992SE |
| K923036 | Urine ChlorideCHJ · Traditional | Heraeus Kulzer, Inc. | 09/09/1992SE |
| K911297 | Chloride ReagentCHJ · Traditional | Intersect Systems, Inc. | 04/16/1991SE |
More from Intersect Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K934014 | Vacusol Plus Dental Vacuum Line Cleaner/DisinfectantLRJ · Traditional | 12/06/1995SE |
| K931141 | Biotrol Amylase CNPG3CIJ · Traditional | 05/26/1993SE |
| K921855 | Biotrol Bicarbonate StandardsJIS · Traditional | 08/03/1992SE |
| K921677 | Biotrol Magnesium (Magon)JGJ · Traditional | 05/26/1992SE |
| K912795 | Biotrol Uibc ReagentJMO · Traditional | 08/12/1991SE |
| K910721 | Biotrol Protein Multilevel StandardsJIS · Traditional | 05/06/1991SE |
| K905683 | Biotrol Lactate Dehydrogenase (L-P)CFJ · Traditional | 03/11/1991SE |
| K905280 | Biotrol Bilirubin C & T ControlJJX · Traditional | 02/04/1991SE |
| K894544 | Biotrol Rub-E.I.A. Test GLFX · Traditional | 08/30/1989SE |
| K891061 | Biotrol Calcium MonoreactifCJY · Traditional | 08/10/1989SE |
Questions and answers
When was Biotrol Chloride cleared by the FDA?
Biotrol Chloride (K890015) received a 510(k) decision of Substantially Equivalent on February 17, 1989, 45 days after the submission was received.
What is the product code of K890015?
The FDA product code is CHJ – Mercuric Thiocyanate, Colorimetry, Chloride, a Class II (moderate risk) device regulated under 21 CFR 862.1170.