Hemoglobinometer Model 720 B
FDA 510(k) K781361 · Innovative Medical Systems, Inc.
510(k) numberK781361
Submission
- Device name
- Hemoglobinometer Model 720 B
- Applicant
- Innovative Medical Systems, Inc.
Mchenry, IL, US - Received
- August 7, 1978
- Decision date
- September 14, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GKR – System, Hemoglobin, Automated
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5620
- Specialty
- Hematology
Other 510(k)s with product code GKR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K201217 | HemoCue Hb 301 SystemGKR · Traditional | Hemocue AB | 08/04/2020SE |
| K200909 | Hemo Control (optional Add Pack Hemo Control DM)GKR · Special | Ekf-Diagnostic GmbH | 06/12/2020SE |
| K181751 | HemoCue Hb 801 SystemGKR · Traditional | Hemocue AB | 02/01/2019SE |
| K182298 | hemochroma PLUS SystemGKR · Traditional | Immunostics Inc., | 11/16/2018SE |
| K172173 | DiaSpect Tm, DiaSpect Tm CuvettesGKR · Traditional | Ekf-Diagnostic GmbH | 04/06/2018SE |
| K163465 | hemochroma PLUS SystemGKR · Traditional | Immunostics Inc., | 09/08/2017SE |
| K122553 | Mission Plus HB Hemoglobin Testing SystemGKR · Traditional | ACON Laboratories, Inc. | 08/05/2013SE |
| K121752 | Avie Total HB Test SystemGKR · Traditional | Mec Dynamics Corp | 01/07/2013SE |
| K110393 | Ekf- Diagnostic Hemo_Control Hemoglobin Measurement System; Ekf-Diagnostic Hemoglobin…GKR · Special | Ekf-Diagnostic GmbH | 03/04/2011SE |
| K090093 | Stanbio Laboratory Hemopoint H2 DM Hemoglobin Measurement SystemGKR · Special | Stanbio Laboratory | 06/10/2009SE |
More from Stanbio Laboratory
| 510(k) | Device | Decision |
|---|---|---|
| K973035 | Viola II Dental Camera SystemEIA · Traditional | 09/24/1997SE |
| K951469 | Bazooka SystemFNM · Traditional | 06/28/1995SE |
| K933184 | Positive Airway Pressure SystemBZD · Traditional | 11/28/1994SE |
| K924590 | Microwave Automated Tissue ProcessorIEO · Traditional | 12/29/1992SE |
| K922081 | Labotech Automated Microtiter AnalyzerJJQ · Traditional | 09/02/1992SE |
| K921005 | AutoloaderJQW · Traditional | 04/29/1992SE |
| K915457 | Phaco 20/20 System IHQC · Traditional | 02/24/1992SE |
| K915456 | Phaco 3000 LinearHQC · Traditional | 02/12/1992SE |
| K883599 | LX-80 Automated Tissue Processor (Plastic)IEO · Traditional | 09/02/1988SE |
| K880745 | LX-100 Slide StainerKPA · Traditional | 04/27/1988SE |
Questions and answers
When was Hemoglobinometer Model 720 B cleared by the FDA?
Hemoglobinometer Model 720 B (K781361) received a 510(k) decision of Substantially Equivalent on September 14, 1978, 38 days after the submission was received.
What is the product code of K781361?
The FDA product code is GKR – System, Hemoglobin, Automated, a Class II (moderate risk) device regulated under 21 CFR 864.5620.