Product code LKL
- Device name
- Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Device class
- 1
- Regulation number
- 866.5420
- Review panel
- IM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K993441 | K-ASSAY ALPHA-1 AG | Kamiya Biomedical Co. | 1999-11-24 |
| K964299 | N-ASSAY TIA MULTI V-NL | Crestat Diagnostics, Inc. | 1997-07-14 |
| K964257 | IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ACID GLYCOPROTEIN (AAG) REAGENT | Beckman Instruments, Inc. | 1997-03-24 |
| K922417 | AL-ACID GLYCOPROTEIN RID KIT | The Binding Site, Ltd. | 1992-08-20 |
| K904175 | RAICHEM (TM) SPIA (TM) - ACID GLYCOPROTEIN REAGENT | Reagents Applications, Inc. | 1990-11-13 |
| K884217 | TECHNICON DPA-1 ANALYTE ALPHA 1 ACID GLYCOPROTEIN | Technicon Instruments Corp. | 1988-11-04 |
| K873868 | ALPHA-1-ACID GLYCOPROTEIN (OROSOMUCOID) | Unipath , Ltd. | 1987-10-20 |
| K862087 | SANTEST 1AP | Scientific Sales Intl., Inc. | 1986-12-03 |
| K861336 | IAP PLATE TEST | Scientific Sales Intl., Inc. | 1986-04-25 |
| K841734 | TAGO FIFFU-GEN, OROSOMUCOID | Tago, Inc. | 1984-06-01 |
| K831960 | TEST FOR HUMAN ALPHA ONE ACID GLYCO- | Kent Laboratories, Inc. | 1983-07-19 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04015630919529 | Tina-quant Alpha 1-Acid Glycoprotein Gen.2 | Roche Diagnostics GmbH | 2021-02-08 |
| 04015630928408 | Tina-quant Alpha 1-Acid Glycoprotein Gen.2 | Roche Diagnostics GmbH | 2021-01-18 |
| 00630414590158 | ADVIA® Chemistry AAG a1-Acid Glycoprotein Reagents | Siemens Healthcare Diagnostics Inc. | 2020-09-24 |
| 00630414596211 | Atellica CH AAG | Siemens Healthcare Diagnostics Inc. | 2020-09-24 |
| 00842768005985 | Dimension Vista® a1-Acid Glycoprotein Flex® reagent cartridge | Siemens Healthcare Diagnostics Products GmbH | 2020-09-24 |
| 07613336130162 | Tina-quant a1-Acid Glycoprotein Gen.2 | Roche Diagnostics GmbH | 2020-03-05 |
| 00380740156428 | ARCHITECT | ABBOTT LABORATORIES | 2020-03-03 |
| 05055273200126 | ALPHA-1-ACID-GLYCOPROTEIN (AGT) | RANDOX LABORATORIES LIMITED | 2019-05-31 |
| 00380740153809 | Alinity | ABBOTT LABORATORIES | 2019-04-10 |
| 00380740054168 | ARCHITECT | ABBOTT LABORATORIES | 2018-07-31 |
| 08058056680648 | alpha 1-Acid Glycoprotein | SENTINEL CH. SPA | 2017-05-15 |
| 15099590010591 | AU | BECKMAN COULTER IRELAND INC. | 2016-09-24 |
| B1761230 | Antiserum to Human Alpha 1 Acid Glycoprotein | KENT LABORATORIES INC | 2016-09-24 |
| 05051700016537 | Human alpha 1 acid glycoprotein Kit for use on SPAPLUS | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 05051700017633 | Optilite Alpha-1-Acid Glycoprotein Kit | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 00816426020146 | K-ASSAY® Alpha-1 AG Reagent | KAMIYA BIOMEDICAL COMPANY, LLC | 2016-09-16 |
| 15099590224066 | IMMAGE | Beckman Coulter, Inc. | 2016-08-24 |