Al-Acid Glycoprotein Rid Kit
FDA 510(k) K922417 · The Binding Site, Ltd.
510(k) numberK922417
Submission
- Device name
- Al-Acid Glycoprotein Rid Kit
- Applicant
- The Binding Site, Ltd.
Los Angeles, CA, US - Received
- May 21, 1992
- Decision date
- August 20, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K964257 | Immage Immunochemistry System ALPHA-1-ACID Glycoprotein (Aag) ReagentLKL · Traditional | Beckman Instruments, Inc. | 03/24/1997SE |
| 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 |
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| K100455 | Spaplus AnalyzerDBI · Traditional | 09/03/2010SE |
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| K092450 | Human Igd Kit for Use on SpaplusCZJ · Traditional | 12/28/2009SE |
| K083289 | Human BETA-2 Microglobulin KitJZG · Traditional | 05/06/2009SE |
| K082129 | Human Igm Liquid Reagent Kit for Use on the Spaplus AnalyzerCFN · Traditional | 02/10/2009SE |
| K081827 | Human Iga Liquid Reagent Kit for Use on SpaplusCFN · Traditional | 12/19/2008SE |
Questions and answers
When was Al-Acid Glycoprotein Rid Kit cleared by the FDA?
Al-Acid Glycoprotein Rid Kit (K922417) received a 510(k) decision of Substantially Equivalent on August 20, 1992, 91 days after the submission was received.
What is the product code of K922417?
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.