Product code JZJ
- Device name
- Prealbumin, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Device class
- 1
- Regulation number
- 866.5060
- 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 |
|---|---|---|---|
| K000661 | RANDOX PREALBUMIN | Randox Laboratories, Ltd. | 2000-04-13 |
| K972638 | TINA-QUANT PREALBUMIN | Boehringer Mannheim Corp. | 1998-01-09 |
| K951966 | HUMAN PREALBUMIN RADIAL IMMUNODIFFUSION KIT | Kent Laboratories, Inc. | 1995-06-01 |
| K913672 | PREALBUMIN IMMUNOLOGICAL NL TEST KIT | The Binding Site, Ltd. | 1991-12-20 |
| K884297 | SPQ(TM) TEST SYSTEM FOR PREALBUMIN | Atlantic Antibodies | 1988-11-02 |
| K884298 | SPQ(TM) TEST SYSTEM FOR MICROALBUMIN | Atlantic Antibodies | 1988-11-02 |
| K883002 | QM300 PREALBUMIN ANTIBODY PACK | Kallestad Diag, A Div. of Erbamont, Inc. | 1988-09-22 |
| K850686 | ANTISERUM TO HUMAN PREALBUMIN | Kent Laboratories, Inc. | 1985-11-01 |
| K851912 | LASER PREALBUMIN TEST | Behring Diagnostics, Inc. | 1985-06-21 |
| K821135 | PREALBUMIN ENZYME IMMUNOASSAY | Abbott Laboratories | 1983-05-05 |
| K772329 | LAS-R HUMAN PREALBUMIN TEST | Hyland Therapeutic Div., Travenol Laboratories | 1978-02-03 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00630414614939 | Atellica CH Prealbumin (PALB) | Siemens Healthcare Diagnostics Inc. | 2024-02-02 |
| 00630414313412 | Atellica CH Prealbumin (PALB) | Siemens Healthcare Diagnostics Inc. | 2024-02-02 |
| 06971674867203 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-24 |
| 06971674867210 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-24 |
| 06971674867258 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-24 |
| 06971674867265 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-24 |
| 06971674867968 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-24 |
| 06971674867227 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-22 |
| 06971674867234 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-22 |
| 06971674867241 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-22 |
| 05055273204759 | PREALBUMIN (PreALB) | RANDOX LABORATORIES LIMITED | 2022-10-05 |
| 00380740169947 | Alinity | ABBOTT IRELAND | 2021-05-19 |
| 04015630913787 | Prealbumin - Application for C.f.a.s. PAC | Roche Diagnostics GmbH | 2021-01-18 |
| 04015630928804 | Prealbumin | Roche Diagnostics GmbH | 2021-01-18 |
| 00630414517704 | ADVIA® Chemistry PREALB Prealbumin Reagents | Siemens Healthcare Diagnostics Inc. | 2020-09-24 |
| 00630414596259 | Atellica CH PreAlb | Siemens Healthcare Diagnostics Inc. | 2020-09-24 |
| 00842768011399 | N Antiserum to Human Prealbumin | Siemens Healthcare Diagnostics Products GmbH | 2020-09-24 |
| 00842768006210 | DImension Vista® Prealbumin Flex® reagent cartridge | Siemens Healthcare Diagnostics Products GmbH | 2020-09-24 |
| 05700572000211 | Poly Rb A-Hu Prealbumin | AGILENT TECHNOLOGIES SINGAPORE PTE LTD | 2020-09-17 |
| 03610230007396 | Yumizen C1200 Prealbumin | HORIBA ABX SAS | 2020-08-31 |
| 10758750006908 | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. | 2020-04-18 |
| 07613336147894 | Prealbumin | Roche Diagnostics GmbH | 2020-03-05 |
| 00380740174897 | ARCHITECT | Abbott GmbH | 2020-02-29 |
| 05051700018135 | Optilite Prealbumin Kit | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 05051700016100 | Human Prealbumin Kit for use on SPAPLUS | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 05051700010771 | Human Prealbumin BINDARID™ Radial Immunodiffusion Kit | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| B1761545 | Prealbumin RID plate kit | KENT LABORATORIES INC | 2016-09-24 |
| B1761540 | Antiserum to Human Prealbumin | KENT LABORATORIES INC | 2016-09-24 |
| 15099590225322 | Synchron | Beckman Coulter, Inc. | 2016-08-24 |
| 03610230005347 | ABX PENTRA PREALBUMIN | HORIBA ABX SAS | 2016-08-16 |