Atlas FDA

hemochroma PLUS System

FDA 510(k) clearance K182298 · decided 2018-11-16

Clearance details

K-number
K182298
Device name
hemochroma PLUS System
Applicant
Immunostics Inc.,
Decision
Substantially Equivalent
Date received
2018-08-24
Decision date
2018-11-16
Days to decision
84 days
Clearance type
Traditional
Product code
GKR
Device class
2
Regulation number
864.5620
Medical specialty
Hematology
Advisory committee
Hematology
Location
Eatontown, NJ, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Immunostics Inc.

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.

RecordFirmDate
HemoCue Hb 301 System (K201217)Hemocue AB2020-08-04
Hemo Control (optional Add Pack Hemo Control DM) (K200909)Ekf-Diagnostic GmbH2020-06-12
HemoCue Hb 801 System (K181751)Hemocue AB2019-02-01
DiaSpect Tm, DiaSpect Tm Cuvettes (K172173)Ekf-Diagnostic GmbH2018-04-06
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 Corp2013-01-07
EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM; EKF-DIAGNOSTIC HEMOGLOBIN MICROCUVETTES (MODIFIED CURVETTE W (K110393)Ekf-Diagnostic GmbH2011-03-04
STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEM (K090093)Stanbio Laboratory2009-06-10
STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM (K081719)Stanbio Laboratory2008-07-18
HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 111801 (K061047)Hemocue AB2006-06-08
HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM (K041234)Hemocue, Inc.2004-06-10

Recalls involving this device

No recalls on record reference this clearance.