Biotrol Urine Proteins Reagent
FDA 510(k) K885053 · Biotrol, USA, Inc.
510(k) numberK885053
Submission
- Device name
- Biotrol Urine Proteins Reagent
- Applicant
- Biotrol, USA, Inc.
Westchester, PA, US - Received
- December 7, 1988
- Decision date
- January 30, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JIR – Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1645
- Specialty
- Clinical Chemistry
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| 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 Urine Proteins Reagent cleared by the FDA?
Biotrol Urine Proteins Reagent (K885053) received a 510(k) decision of Substantially Equivalent on January 30, 1989, 54 days after the submission was received.
What is the product code of K885053?
The FDA product code is JIR – Indicator Method, Protein Or Albumin (Urinary, Non-Quant.), a Class I (low risk) device regulated under 21 CFR 862.1645.