Spq(Tm) Test System for Apolipoprotein Al
FDA 510(k) K870862 · Atlantic Antibodies
510(k) numberK870862
Submission
- Device name
- Spq(Tm) Test System for Apolipoprotein Al
- Applicant
- Atlantic Antibodies
Scarborough, ME, US - Received
- March 3, 1987
- Decision date
- March 24, 1987
- 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 |
|---|---|---|
| K892526 | SPQ TM Test System II for CRPDCK · Traditional | 05/09/1989SE |
| K891154 | Spq(Tm) Antibody Reagent Set II for Apo A-I/Apo BMSJ · Traditional | 03/16/1989SE |
| K890563 | Spq(Tm) Antibody Reagent Set II for TRFDDG · Traditional | 03/03/1989SE |
| K890561 | Spq(Tm) Antibody Reagent Set II for IgmCFQ · Traditional | 02/23/1989SE |
| K890562 | Spq(Tm) Antibody Reagent Set II for HPTDAD · Traditional | 02/22/1989SE |
| K890416 | Spq(Tm) Antibody Reagent Set II for IggDEW · Traditional | 02/22/1989SE |
| K890564 | Spq(Tm) Antibody Reagent Set II for C4DBI · Traditional | 02/17/1989SE |
| K890417 | Spq(Tm) Antibody Reagent Set II for C3KTQ · Traditional | 02/17/1989SE |
| K890415 | Spq(Tm) Antibody Reagent Set II for AatDEM · Traditional | 02/17/1989SE |
| K890560 | Spq(Tm) Antibody Reagent Set II for IgaCZP · Traditional | 02/15/1989SE |
Questions and answers
When was Spq(Tm) Test System for Apolipoprotein Al cleared by the FDA?
Spq(Tm) Test System for Apolipoprotein Al (K870862) received a 510(k) decision of Substantially Equivalent on March 24, 1987, 21 days after the submission was received.
What is the product code of K870862?
The FDA product code is MSJ – Apolipoproteins, a Class I (low risk) device regulated under 21 CFR 862.1475.