Biotrol Calcium Monoreactif
FDA 510(k) K891061 · Biotrol, USA, Inc.
510(k) numberK891061
Submission
- Device name
- Biotrol Calcium Monoreactif
- Applicant
- Biotrol, USA, Inc.
Westchester, PA, US - Received
- March 1, 1989
- Decision date
- August 10, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CJY – Azo Dye, Calcium
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1145
- Specialty
- Clinical Chemistry
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| K083386 | Advia Chemistry CALCIUM_2 (CA_2) Method, Models P/M 02189699 (40 ML Fill), P/N 02189915…CJY · Traditional | Siemens Healthcare Diagnostics | 04/02/2009SE |
| K072356 | S-Test CaCJY · Traditional | Alfa Wassermann Diagnostic Technologies, Inc. | 06/24/2008SE |
| K073355 | Calcium, Scal, Nortrol, AbtrolCJY · Traditional | Thermofisher Scientific OY | 02/28/2008SE |
| K072443 | Vitros Chemistry Products Ca DT Slides and DT Calibrator Kit and Vitros Ca AssayCJY · Special | Ortho-Clinical Diagnostics, Inc. | 09/24/2007SE |
More from Ortho-Clinical Diagnostics, 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 |
| K891286 | Biotrol Chemistry Urine ControlJJW · Traditional | 04/10/1989SE |
Questions and answers
When was Biotrol Calcium Monoreactif cleared by the FDA?
Biotrol Calcium Monoreactif (K891061) received a 510(k) decision of Substantially Equivalent on August 10, 1989, 162 days after the submission was received.
What is the product code of K891061?
The FDA product code is CJY – Azo Dye, Calcium, a Class II (moderate risk) device regulated under 21 CFR 862.1145.