Product code GLK
- Device name
- Control, Hematocrit
- Medical specialty
- Hematology
- Device class
- 2
- Regulation number
- 864.8625
- 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 |
|---|---|---|---|
| K121467 | EUROTROL HEMATOCRIT CONTROL | Eurotrol B.V. | 2013-05-10 |
| K021924 | MEDICA EASYQC HEMATOCRIT CONTROL | Bionostics, Inc. | 2002-06-24 |
| K020618 | AALTO SCIENTIFIC MIRCO HEMATOCRIT CONTROL | Aalto Scientific, Ltd. | 2002-05-14 |
| K964452 | HEMATACHEK | Richmond Diagnostics, Inc. | 1997-02-20 |
| K961807 | CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4 | Ciba Corning Diagnostics Corp. | 1996-07-26 |
| K924926 | MSI-HCT | Medical Specialties, Inc. | 1993-01-07 |
| K893562 | A.QC HCT LEVEL 1 AND 2 | Johnson & Johnson Professionals, Inc. | 1989-07-14 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08426951293858 | GEM ChemSTAT critPVP 1-4 | INSTRUMENTATION LABORATORY COMPANY | 2019-06-26 |
| 08426951293841 | ChemSTAT Hematocrit Evaluator 3 | INSTRUMENTATION LABORATORY COMPANY | 2019-06-26 |
| 08426951293834 | ChemSTAT Hematocrit Evaluator 2 | INSTRUMENTATION LABORATORY COMPANY | 2019-06-26 |
| 08426951293827 | ChemSTAT Hematocrit Evaluator 1 | INSTRUMENTATION LABORATORY COMPANY | 2019-06-26 |
| 00831829000205 | HemataChek High Control | SEPARATION TECHNOLOGY, INC. | 2017-08-25 |
| 00831829000182 | HemataChek Normal Control | SEPARATION TECHNOLOGY, INC. | 2017-08-25 |
| 00831829000168 | HemataChek Low Control | SEPARATION TECHNOLOGY, INC. | 2017-08-25 |
| 00831829000151 | HemataChek, Normal & High Control | SEPARATION TECHNOLOGY, INC. | 2017-08-25 |
| 00831829000144 | HemataChek, Low & Normal Control | SEPARATION TECHNOLOGY, INC. | 2017-08-25 |
| 00831829000137 | HemataChek, Low, Normal, High Control | SEPARATION TECHNOLOGY, INC. | 2017-08-25 |
| 00630414121796 | RAPIDQC® Hct Level B | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414121789 | RAPIDQC® Hct Level A | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 08426950573685 | GEM Hematocrit Evaluator 3 | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 08426950573678 | GEM Hematocrit Evaluator 2 | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 08426950573661 | GEM Hematocrit Evaluator 1 | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 08426950446248 | GEM CVP (Calibration Valuation Product) 4 Hematocrit | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 08426950446231 | GEM CVP (Calibration Valuation Product) 3 Hematocrit | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 08426950046660 | Hct Check - High Level | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 08426950046653 | Hct Check - Low Level | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 08426950511526 | IL critPVP | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 08426950452058 | GEM critCheck | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 06944413801875 | Blood Gas and Chemistry Analyzer | Edan Instruments, Inc. | 2016-09-01 |
| 06944413802018 | Hematocrit Control | Edan Instruments, Inc. | 2016-09-01 |
| 06944413802025 | Hematocrit Control | Edan Instruments, Inc. | 2016-09-01 |
| 08718734960478 | Eurotrol | Eurotrol B.V. | 2016-08-26 |
| 08718734960454 | Eurotrol | Eurotrol B.V. | 2016-08-26 |
| 08718734960430 | Eurotrol | Eurotrol B.V. | 2016-08-26 |
| 08718734960423 | Eurotrol | Eurotrol B.V. | 2016-08-26 |