BIOTROL-33 Plus Pathologique Assayed Chem. Control
FDA 510(k) K872777 · Biotrol, USA, Inc.
510(k) numberK872777
Submission
- Device name
- BIOTROL-33 Plus Pathologique Assayed Chem. Control
- Applicant
- Biotrol, USA, Inc.
Berwyn, PA, US - Received
- July 14, 1987
- Decision date
- August 26, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JJY – Multi-Analyte Controls, All Kinds (Assayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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More from Aalto Scientific, Ltd.
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| 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-33 Plus Pathologique Assayed Chem. Control cleared by the FDA?
BIOTROL-33 Plus Pathologique Assayed Chem. Control (K872777) received a 510(k) decision of Substantially Equivalent on August 26, 1987, 43 days after the submission was received.
What is the product code of K872777?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.