Diffu-Gen Apolipoprotein A-I Radial -
FDA 510(k) K834218 · Tago, Inc.
510(k) numberK834218
Submission
- Device name
- Diffu-Gen Apolipoprotein A-I Radial -
- Applicant
- Tago, Inc.
Walker, MI, US - Received
- December 8, 1983
- Decision date
- May 11, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- MSJ – Apolipoproteins
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1475
- Specialty
- Clinical Chemistry
Other 510(k)s with product code MSJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K072977 | Diazyme Apolipoprotein A-1 AssayMSJ · Traditional | General Atomics | 07/16/2008SE |
| K073488 | Diazyme Apolipoprotein B Assay, Model Dzxxx-X; B Calibrator, Model DzxxxMSJ · Traditional | Diazyme Laboratories | 03/07/2008SE |
| K061377 | Apolipoprotein A1 and Apolipoprotein B Reagents and CalibratorsMSJ · Traditional | Pointe Scientific, Inc., | 03/28/2007SE |
| K063608 | Dimension Vista APOA1 and Apob Flex Reagent Cartridges and Protein 1 Calibrator and…MSJ · Traditional | Dade Behring, Inc. | 02/23/2007SE |
| K992662 | 8 Additional Assays for the Bayer Advia 1650 Chemistry SystemMSJ · Traditional | Bayer Corp. | 02/15/2000SE |
| K970314 | Synchron LX Systems Apolipoprotein (Apoa and Apob) ReagentsMSJ · Traditional | Beckman Instruments, Inc. | 04/21/1997SE |
| K964010 | Immage Immunochemistry System Apolipoprotein A-1 Reagent (Apa)/ Immage Immunochemistry…MSJ · Traditional | Beckman Instruments, Inc. | 02/10/1997SE |
| K931777 | Apo A-1 Chemiluminescence AssayMSJ · Traditional | Nichols Institute | 08/16/1993SE |
| K925702 | Nichols Apo B Chemiluminescence AssayMSJ · Traditional | Nichols Institute Diagnostics | 12/23/1992SE |
| K923087 | Il Test Apolipoprotein A1MSJ · Traditional | Instrumentation Laboratory CO | 10/26/1992SE |
More from Instrumentation Laboratory CO
| 510(k) | Device | Decision |
|---|---|---|
| K841734 | Tago Fiffu-Gen, OrosomucoidLKL · Traditional | 06/01/1984SE |
| K841265 | Tago Diffu-Gen C-Reactive ProteinDCN · Traditional | 05/22/1984SE |
| K840404 | Diffu-Gen Haptoglobin Radial ImmunoDAD · Traditional | 03/09/1984SE |
| K833129 | Tago Diffu-Gen-Apolipoprotein B-100MSJ · Traditional | 11/21/1983SE |
| K830611 | Ra Screening TestDHR · Traditional | 03/24/1983SE |
| K830531 | Mono Screening TestKTN · Traditional | 03/17/1983SE |
| K830156 | HCG Screening TestJHJ · Traditional | 02/09/1983SE |
Questions and answers
When was Diffu-Gen Apolipoprotein A-I Radial - cleared by the FDA?
Diffu-Gen Apolipoprotein A-I Radial - (K834218) received a 510(k) decision of Substantially Equivalent on May 11, 1984, 155 days after the submission was received.
What is the product code of K834218?
The FDA product code is MSJ – Apolipoproteins, a Class I (low risk) device regulated under 21 CFR 862.1475.