Beckman ALPHA-1-MICROGLOBULIN (A1M) Reagent
FDA 510(k) K933078 · Beckman Instruments, Inc.
510(k) numberK933078
Submission
- Device name
- Beckman ALPHA-1-MICROGLOBULIN (A1M) Reagent
- Applicant
- Beckman Instruments, Inc.
Brea, CA, US - Received
- June 23, 1993
- Decision date
- January 11, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MGA – Alpha-1 Microglobulin, Antigen, Antiserum, Control
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.5400
- Specialty
- Immunology
Other 510(k)s with product code MGA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K965033 | Immage Immunochemistry System ALPHA-1-MICROGLOBULIN (Ai) ReagentMGA · Traditional | Beckman Instruments, Inc. | 04/21/1997SE |
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| K982250 | Access Free T4 Reagents on the Access Immunoassay AnalyzerCEC · Traditional | 07/14/1998SE |
| K981403 | Immage Immunochemistry System Valproic Acid (Vpa) ReagentDKB · Traditional | 05/08/1998SE |
| K981354 | Access Afp Reagents on the Access Immunoassay Analyzer Model Number 33211LOJ · Traditional | 05/01/1998SE |
| K980173 | Access Total BHCG Reagents on the Access Immunoassay Analyzer; 33500, 33505JHI · Traditional | 03/18/1998SE |
| K974816 | Access(R) Psa Reagents on the Access(R) Immunoassay Analyzer 33220, 33225, 33229LTJ · Traditional | 02/20/1998SE |
| K974564 | Immage Immunochemistry System ALPHA-2-MACROGLOBULIN ReagentDEB · Traditional | 02/17/1998SE |
| K974110 | Immage Immunochemistry System Antithrombin III (AT3) ReagentJBQ · Traditional | 12/24/1997SE |
| K974452 | Vigil Lipid ControlJJY · Traditional | 12/17/1997SE |
| K973932 | Beckman Calibrator 2 (CAL2)JIX · Traditional | 12/15/1997SE |
Questions and answers
When was Beckman ALPHA-1-MICROGLOBULIN (A1M) Reagent cleared by the FDA?
Beckman ALPHA-1-MICROGLOBULIN (A1M) Reagent (K933078) received a 510(k) decision of Substantially Equivalent on January 11, 1994, 202 days after the submission was received.
What is the product code of K933078?
The FDA product code is MGA – Alpha-1 Microglobulin, Antigen, Antiserum, Control, a Class I (low risk) device regulated under 21 CFR 866.5400.