Bi-Crp Latex Test
FDA 510(k) K811374 · Biologics Intl., Inc.
510(k) numberK811374
Submission
- Device name
- Bi-Crp Latex Test
- Applicant
- Biologics Intl., Inc.
Mchenry, IL, US - Received
- May 15, 1981
- Decision date
- June 12, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DCN – System, Test, C-Reactive Protein
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5270
- Specialty
- Immunology
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| K091052 | Piccolo C-Reactive Protein (CRP) Test SystemDCN · Traditional | Abaxis, Inc. | 01/15/2010SE |
| K083444 | C-Reactive Protein (Latex)DCN · Traditional | Roche Diagnostics Corp. | 03/18/2009SE |
More from Roche Diagnostics Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K882229 | Air Bed & Flotation Dermagard 800 & 900 SystemsIOQ · Traditional | 08/16/1988SE |
| K823353 | Carcino-CekJJX · Traditional | 12/14/1982SE |
| K812060 | Bi-Aso Slide TestGTQ · Traditional | 08/13/1981SE |
| K811375 | Bi-Ra Slide TestDHR · Traditional | 06/12/1981SE |
| K800605 | Ana Latex Slide TestDHC · Traditional | 04/02/1980SE |
| K791609 | Be-SureJHJ · Traditional | 10/02/1979SE |
| K791607 | Beta-CellJSG · Traditional | 09/24/1979SE |
| K790898 | Preg-TexJHJ · Traditional | 07/30/1979SE |
Questions and answers
When was Bi-Crp Latex Test cleared by the FDA?
Bi-Crp Latex Test (K811374) received a 510(k) decision of Substantially Equivalent on June 12, 1981, 28 days after the submission was received.
What is the product code of K811374?
The FDA product code is DCN – System, Test, C-Reactive Protein, a Class II (moderate risk) device regulated under 21 CFR 866.5270.