Tago Fiffu-Gen, Orosomucoid
FDA 510(k) K841734 · Tago, Inc.
510(k) numberK841734
Submission
- Device name
- Tago Fiffu-Gen, Orosomucoid
- Applicant
- Tago, Inc.
Mchenry, IL, US - Received
- April 26, 1984
- Decision date
- June 1, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| 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 |
| K831960 | Test for Human Alpha One Acid Glyco-LKL · Traditional | Kent Laboratories, Inc. | 07/19/1983SE |
More from Kent Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K841265 | Tago Diffu-Gen C-Reactive ProteinDCN · Traditional | 05/22/1984SE |
| K834218 | Diffu-Gen Apolipoprotein A-I Radial -MSJ · Traditional | 05/11/1984SE |
| 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 Tago Fiffu-Gen, Orosomucoid cleared by the FDA?
Tago Fiffu-Gen, Orosomucoid (K841734) received a 510(k) decision of Substantially Equivalent on June 1, 1984, 36 days after the submission was received.
What is the product code of K841734?
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.