Product code KSG
- Device name
- Media, Potentiating For In Vitro Diagnostic Use
- Medical specialty
- Hematology
- Device class
- 2
- Regulation number
- 864.9600
- Review panel
- HE
- 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 |
|---|---|---|---|
| K812565 | ELUTION SOLUTION | Biological Corp. of America | 1981-10-23 |
| K812222 | EM-X | Biological Corp. of America | 1981-09-23 |
| K800943 | PENTEX BOVINE ALBUMIN 30% SOLUTION | Miles Laboratories, Inc. | 1980-05-08 |
| K800189 | BOVINE ALBUMIN 22% & 30% SOLUTIONS | Gotham Biologics, Inc. | 1980-02-13 |
| K791791 | ORTHO ANTIBODY ENHANCEMENT SOLUTION | Ortho Diagnostics, Inc. | 1979-10-11 |
| K791113 | LOW IONIC STRENGTH SOLUTION (LISS) | Hyland Therapeutic Div., Travenol Laboratories | 1979-06-28 |
| K790973 | LO-ION | Gamma Biologicals, Inc. | 1979-06-15 |
| K790776 | DADE LOW IONIC STRENGTH SOLUITION (LISS) | Dade, Baxter Travenol Diagnostics, Inc. | 1979-05-23 |
| K790498 | LISS REAGENT | Fisher Scientific Co., LLC | 1979-04-03 |
| K781397 | EM-V | Biological Corp. of America | 1978-09-14 |
| K781435 | ORTHO LOW IONIC SOLUTION | Ortho Diagnostics, Inc. | 1978-09-14 |
| K780413 | LOW IIONIC STRENGTH SOLUTION | Pfizer, Inc. | 1978-04-24 |
| K780556 | SPECT RIM (LISS) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-04-24 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 05060242477959 | ALBA Elution Kit | ALBA BIOSCIENCE LIMITED | 2023-10-13 |
| 07611969964505 | IH-Titration Rack | Bio-Rad Medical Diagnostics GmbH | 2022-03-09 |
| 07611969952205 | IH-Titration Solution | Bio-Rad Medical Diagnostics GmbH | 2022-03-03 |
| 00858400005121 | LISS | American National Red Cross | 2018-09-17 |
| 10858400005128 | LISS | AMERICAN NATIONAL RED CROSS | 2018-09-17 |
| 10858400005104 | PEG | AMERICAN NATIONAL RED CROSS | 2018-09-17 |
| 00858400005107 | PEG | American National Red Cross | 2018-09-17 |
| 23661562105445 | LISS | DIAGAST | 2018-05-01 |
| 07611969952182 | IH-LISS Solution | Bio-Rad Medical Diagnostics GmbH | 2018-04-05 |
| 07611969069934 | IH-LISS Rack | Bio-Rad Medical Diagnostics GmbH | 2017-01-20 |
| 00858352006023 | ELUclear | HEMO BIOSCIENCE INC | 2016-09-27 |
| 10758750007820 | ORTHO | ORTHO-CLINICAL DIAGNOSTICS, INC. | 2016-08-24 |
| 10758750006038 | MTS | MICRO TYPING SYSTEMS, INC | 2016-08-24 |
| 10758750007837 | ORTHO | ORTHO-CLINICAL DIAGNOSTICS, INC. | 2016-08-24 |
| 10758750006045 | MTS | MICRO TYPING SYSTEMS, INC | 2016-08-24 |
| 10888234001775 | Gamma LO-ION | IMMUCOR, INC. | 2016-04-15 |
| 10888234001782 | Gamma PeG | IMMUCOR, INC. | 2016-04-15 |
| 10888234001799 | Gamma PeG | IMMUCOR, INC. | 2016-04-15 |
| 10888234001805 | Gamma N-HANCE | IMMUCOR, INC. | 2016-04-15 |
| 10888234001812 | Gamma N-HANCE | IMMUCOR, INC. | 2016-04-15 |
| 10888234000235 | Bovine Albumin Solution 22% | IMMUCOR, INC. | 2016-04-15 |
| 10888234000167 | ImmuAdd | IMMUCOR, INC. | 2016-04-15 |
| 10888234000877 | Gamma EGA Kit | IMMUCOR, INC. | 2016-04-14 |
| 10888234000860 | Gamma ELU-KIT II | IMMUCOR, INC. | 2016-04-14 |
| 05060242471520 | Bovine Serum Albumin 22% | ALBA BIOSCIENCE LIMITED | 2014-11-14 |
| 05060242471537 | ALBAhance PEG | ALBA BIOSCIENCE LIMITED | 2014-11-14 |