Hemo Control (optional Add Pack Hemo Control DM)
FDA 510(k) clearance K200909 · decided 2020-06-12
Clearance details
- K-number
- K200909
- Device name
- Hemo Control (optional Add Pack Hemo Control DM)
- Applicant
- Ekf-Diagnostic GmbH
- Decision
- Substantially Equivalent
- Date received
- 2020-04-06
- Decision date
- 2020-06-12
- Days to decision
- 67 days
- Clearance type
- Special
- Product code
- GKR
- Device class
- 2
- Regulation number
- 864.5620
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Barleben, DE
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Ekf-Diagnostic GmbH
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| HemoCue Hb 301 System (K201217) | Hemocue AB | 2020-08-04 |
| HemoCue Hb 801 System (K181751) | Hemocue AB | 2019-02-01 |
| hemochroma PLUS System (K182298) | Immunostics Inc., | 2018-11-16 |
| DiaSpect Tm, DiaSpect Tm Cuvettes (K172173) | Ekf-Diagnostic GmbH | 2018-04-06 |
| hemochroma PLUS System (K163465) | Immunostics Inc., | 2017-09-08 |
| MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM (K122553) | ACON Laboratories, Inc. | 2013-08-05 |
| AVIE TOTAL HB TEST SYSTEM (K121752) | Mec Dynamics Corp | 2013-01-07 |
| EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM; EKF-DIAGNOSTIC HEMOGLOBIN MICROCUVETTES (MODIFIED CURVETTE W (K110393) | Ekf-Diagnostic GmbH | 2011-03-04 |
| STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEM (K090093) | Stanbio Laboratory | 2009-06-10 |
| STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM (K081719) | Stanbio Laboratory | 2008-07-18 |
| HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 111801 (K061047) | Hemocue AB | 2006-06-08 |
| HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM (K041234) | Hemocue, Inc. | 2004-06-10 |
Recalls involving this device
No recalls on record reference this clearance.