Biotrol Bicarbonate Standards
FDA 510(k) K921855 · Biotrol, USA, Inc.
510(k) numberK921855
Submission
- Device name
- Biotrol Bicarbonate Standards
- Applicant
- Biotrol, USA, Inc.
Exton, PA, US - Received
- April 17, 1992
- Decision date
- August 3, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JIS – Calibrator, Primary
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1150
- Specialty
- Clinical Chemistry
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More from Wako Chemicals USA, Inc.
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| 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 |
| K891286 | Biotrol Chemistry Urine ControlJJW · Traditional | 04/10/1989SE |
Questions and answers
When was Biotrol Bicarbonate Standards cleared by the FDA?
Biotrol Bicarbonate Standards (K921855) received a 510(k) decision of Substantially Equivalent on August 3, 1992, 108 days after the submission was received.
What is the product code of K921855?
The FDA product code is JIS – Calibrator, Primary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.