Product code GKF
- Device name
- Instrument, Hematocrit, Automated
- Medical specialty
- Hematology
- Device class
- 2
- Regulation number
- 864.5600
- 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 |
|---|---|---|---|
| K160415 | GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation) | Instrumentation Laboratory CO | 2016-12-14 |
| K983551 | CRIT-SCAN II MONITOR | In-Line Diagnostics Corp. | 1999-05-27 |
| K981425 | STAT PROFILE ULTRA A, B, C, D, AND E ANALYZERS | Nova Biomedical Corp. | 1998-05-12 |
| K981426 | STAT PROFILE ULTRA F,G,H,I,J,K, AND L ANALYZERS | Nova Biomedical Corp. | 1998-05-12 |
| K981427 | STAT PROFILE M ANALYZER | Nova Biomedical Corp. | 1998-05-12 |
| K953519 | MICROSPIN 24 | Vulcon Technologies | 1995-11-03 |
| K915825 | MARATHON 6K GENERAL-PURPOSE CENTRIFUGE | Fisher Scientific Co., LLC | 1992-03-11 |
| K915441 | MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGE | Fisher Scientific Co., LLC | 1992-01-08 |
| K904336 | NEW COBE SATURATION/HEMATOCRIT MONITOR | Cobe Laboratories, Inc. | 1990-12-27 |
| K880373 | IONOMETER E-HK AND ACCESSORIES | Smash Ent., Inc. | 1988-03-17 |
| K870860 | CHEMPRO 1000(TM) | Arden Medical Systems, Inc. | 1987-04-14 |
| K864646 | SORVALL CAPSPIN MICROHEMATOCRIT CENTRIFUGE | E.I. Dupont DE Nemours & Co., Inc. | 1987-01-05 |
| K864039 | MICROHEMATOCRIT CENTRIFUGE | Plaza Medical, Inc. | 1986-10-29 |
| K802199 | STAT-CRIT HEMATOCRIT MEASURING INSTRU | United States Surgical, A Division of Tyco Healthc | 1981-02-04 |
| K781059 | CUTTER/COMPUR MINI CENTRIFUGE | Cutter Laboratories, Inc. | 1978-08-14 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00386100002596 | pH/pCO2/pO2/Na/K/Ca Analyzer | MEDICA CORPORATION | 2018-12-05 |
| 00386100002633 | Bi-Level QC Kit, HCT | MEDICA CORPORATION | 2018-12-05 |
| 00386100003739 | pH/pCO2/pO2/Na/K/Ca Analyzer | MEDICA CORPORATION | 2018-12-05 |
| 00386100003630 | pH/pCO2/pO2/Na/K/Cl Analyzer | MEDICA CORPORATION | 2018-12-05 |
| 00386100002664 | Reagent Module | MEDICA CORPORATION | 2018-12-05 |
| 00386100002398 | Daily Cleaning Solution Kit | MEDICA CORPORATION | 2018-12-04 |
| 08426950807537 | GEM Premier 5000 PAK BG/COOX 75 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 00385480528566 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2017-07-06 |
| 00385480528573 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2017-07-06 |
| 00385480534208 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2017-07-06 |
| 00385480536561 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2017-07-06 |
| 00385480536578 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2017-07-06 |
| 00385480536660 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2017-07-06 |
| 00385480536677 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2017-07-06 |
| 00630414016627 | RAPIDSystems™ AutomaticQC Cartridge | Siemens Healthcare Diagnostics Inc. | 2017-01-23 |
| 00630414443485 | RAPIDPoint® 400/405/500 Wash/Waste Cartridge | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414443492 | RAPIDPoint® 400 Measurement Cartridge | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00385480552639 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480552646 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480567251 | Stat Profile | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480567268 | Stat Profile | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480528658 | Stat Profile | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480526692 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480526173 | Stat Profile | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480526166 | Stat Profile | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480525824 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480524841 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480420433 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480420334 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480420327 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |