Compur* M1100 Hematrcrit System
FDA 510(k) K831318 · Worthington Diagnostic Systems
510(k) numberK831318
Submission
- Device name
- Compur* M1100 Hematrcrit System
- Applicant
- Worthington Diagnostic Systems
Mchenry, IL, US - Received
- April 22, 1983
- Decision date
- June 8, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JPI – Device, Hematocrit Measuring
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.6400
- Specialty
- Hematology
Other 510(k)s with product code JPI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K183680 | i-STAT CHEM8+ cartridge with the i-STAT 1 SystemJPI · Traditional | Abbott Point of Care, Inc. | 02/28/2020SE |
| K163342 | i-STAT Hematocrit test with i-STAT Alinity SystemJPI · Traditional | Abbott Laboratories | 08/22/2017SE |
| K950942 | Crit-Line Hematocrit AlertJPI · Traditional | In-Line Diagnostics Corp. | 03/14/1995SE |
| K924167 | Crit-LineJPI · Traditional | Noninvasive Medical Technology Corp. | 05/07/1993SE |
| K903698 | Statspin Micro-Hematocrit Reader for 75MM TubesJPI · Traditional | Statspin Technologies | 09/17/1990SE |
| K902028 | Statspin Illuminated Micro-Hematocrit Tube ReaderJPI · Traditional | Norfolk Scientific, Inc. | 06/20/1990SE |
| K870511 | Chart-Type Micro Hematocrit Tube ReaderJPI · Traditional | Norfolk Scientific, Inc. | 03/16/1987SE |
| K852516 | Centifuge, Hematocrit & Microsedimentation CombineJPI · Traditional | Whittaker General Medical | 07/15/1985SE |
| K852482 | Microspin Minicentrifuge Item No. 65204/94JPI · Traditional | Em Diagnostic Systems, Inc. | 07/15/1985SE |
| K850391 | Plasma Extraction SystemJPI · Traditional | Hans J. Brouwers & Assoc. | 05/10/1985SE |
More from Hans J. Brouwers & Assoc.
| 510(k) | Device | Decision |
|---|---|---|
| K833708 | Compur* M1000 Hemoglobin & ErythrocyteLKZ · Traditional | 01/04/1984SE |
| K832785 | Compur* Easy Touch Uric Acid ReagentKNK · Traditional | 10/14/1983SE |
| K832749 | Easytouch Bun Reagent SetCDQ · Traditional | 10/14/1983SE |
| K832748 | Compur* Easytouch Total BilirubinCIG · Traditional | 10/14/1983SE |
| K832427 | Easytouch Tromboplastin ReagentGJS · Traditional | 10/14/1983SE |
| K832750 | Easytouch Hemoglobin ReagentKHG · Traditional | 09/26/1983SE |
| K832426 | Easytouch Triglycerides Reagent SetCDT · Traditional | 09/12/1983SE |
| K831477 | Demand Analyzer SystemJJE · Traditional | 06/17/1983SE |
| K831227 | Compur Easy Touch Chemistry Analyzer-JJF · Traditional | 06/02/1983SE |
| K831103 | Tia-Igm Reagent & Calibrator SetsDFT · Traditional | 04/27/1983SE |
Questions and answers
When was Compur* M1100 Hematrcrit System cleared by the FDA?
Compur* M1100 Hematrcrit System (K831318) received a 510(k) decision of Substantially Equivalent on June 8, 1983, 47 days after the submission was received.
What is the product code of K831318?
The FDA product code is JPI – Device, Hematocrit Measuring, a Class II (moderate risk) device regulated under 21 CFR 864.6400.