Immage Immunochemistry System ALPHA-1-ACID Glycoprotein (Aag) Reagent
FDA 510(k) K964257 · Beckman Instruments, Inc.
510(k) numberK964257
Submission
- Device name
- Immage Immunochemistry System ALPHA-1-ACID Glycoprotein (Aag) Reagent
- Applicant
- Beckman Instruments, Inc.
Brea, CA, US - Received
- October 25, 1996
- Decision date
- March 24, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LKL – Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.5420
- Specialty
- Immunology
Other 510(k)s with product code LKL
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|---|---|---|---|
| K993441 | K-Assay ALPHA-1 AGLKL · Traditional | Kamiya Biomedical Co. | 11/24/1999SE |
| K964299 | N-Assay Tia Multi V-NlLKL · Traditional | Crestat Diagnostics, Inc. | 07/14/1997SE |
| K922417 | Al-Acid Glycoprotein Rid KitLKL · Traditional | The Binding Site, Ltd. | 08/20/1992SE |
| K904175 | Raichem (TM) Spia (TM) - Acid Glycoprotein ReagentLKL · Traditional | Reagents Applications, Inc. | 11/13/1990SE |
| K884217 | Technicon DPA-1 Analyte Alpha 1 Acid GlycoproteinLKL · Traditional | Technicon Instruments Corp. | 11/04/1988SE |
| K873868 | ALPHA-1-ACID Glycoprotein (Orosomucoid)LKL · Traditional | Unipath , Ltd. | 10/20/1987SE |
| K862087 | Santest 1APLKL · Traditional | Scientific Sales Intl., Inc. | 12/03/1986SE |
| K861336 | Iap Plate TestLKL · Traditional | Scientific Sales Intl., Inc. | 04/25/1986SE |
| K841734 | Tago Fiffu-Gen, OrosomucoidLKL · Traditional | Tago, Inc. | 06/01/1984SE |
| K831960 | Test for Human Alpha One Acid Glyco-LKL · Traditional | Kent Laboratories, Inc. | 07/19/1983SE |
More from Kent Laboratories, Inc.
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|---|---|---|
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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 Immage Immunochemistry System ALPHA-1-ACID Glycoprotein (Aag) Reagent cleared by the FDA?
Immage Immunochemistry System ALPHA-1-ACID Glycoprotein (Aag) Reagent (K964257) received a 510(k) decision of Substantially Equivalent on March 24, 1997, 150 days after the submission was received.
What is the product code of K964257?
The FDA product code is LKL – Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control, a Class I (low risk) device regulated under 21 CFR 866.5420.