510(k) K041234
- Device
- HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM
- Applicant
- HEMOCUE, INC.
- 510(k) number
- K041234
- Product code
- GKR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-06-10
- Date received
- 2004-05-10
- Regulation
- 864.5620
- Classification name
- System, Hemoglobin, Automated
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- R.J. SLOMOFF
- Address
- 9229 Cranford Dr. Potomac MD US 20854 20854
FDA Registration Numbers#
- 3014506106
- 9615507
- 2432235
- 3013513377
- 3006198300
- 9610633
- 1649661
- 3009491259
- 1616487
- 1220649
- 3023162659
- 3002807968
- 9610126
- 3043226252
- 1219029
- 3003795116
- 2244821
- 1217183
- 3003044483
- 3004102403
- 3002637618
- 3037000637
- 3004838836
- 2431530
- 3007490412
- 3012494290
- 3030733800
- 3005146144
- 2531491
- 1219913
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GKR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K201217 | HemoCue Hb 301 System | Hemocue AB | 2020-08-04 |
| K200909 | Hemo Control (optional Add Pack Hemo Control DM) | Ekf-Diagnostic GmbH | 2020-06-12 |
| K181751 | HemoCue Hb 801 System | Hemocue AB | 2019-02-01 |
| K182298 | hemochroma PLUS System | Immunostics Inc., | 2018-11-16 |
| K172173 | DiaSpect Tm, DiaSpect Tm Cuvettes | Ekf-Diagnostic GmbH | 2018-04-06 |
| K163465 | hemochroma PLUS System | Immunostics Inc., | 2017-09-08 |
| K122553 | MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM | ACON Laboratories, Inc. | 2013-08-05 |
| K121752 | AVIE TOTAL HB TEST SYSTEM | Mec Dynamics Corp | 2013-01-07 |
| K110393 | EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM; EKF-DIAGNOSTIC HEMOGLOBIN MICROCUVETTES (MODIFIED CURVETTE W | Ekf-Diagnostic GmbH | 2011-03-04 |
| K090093 | STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEM | Stanbio Laboratory | 2009-06-10 |
| K081719 | STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM | Stanbio Laboratory | 2008-07-18 |
| K061047 | HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 111801 | Hemocue AB | 2006-06-08 |
| K032482 | STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM | Stanbio Laboratory | 2003-10-24 |
| K031898 | EKF DIAGNOSTIC HEMO CONTROL HEMOGLOBIN MEASUREMENT SYSTEM | Ekf Diagnostic GmbH | 2003-09-24 |
| K032203 | HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704 | Hemocue, Inc. | 2003-08-25 |
Legacy Summary#
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FDA Review#
Decision Summary