Compur* M1000 Hemoglobin & Erythrocyte
FDA 510(k) K833708 · Worthington Diagnostic Systems
510(k) numberK833708
Submission
- Device name
- Compur* M1000 Hemoglobin & Erythrocyte
- Applicant
- Worthington Diagnostic Systems
Mchenry, IL, US - Received
- October 20, 1983
- Decision date
- January 4, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LKZ – Red-Cell Count By Photometry
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7100
- Specialty
- Hematology
Other 510(k)s with product code LKZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K832771 | Erythrocyte TestLKZ · Traditional | Bio-Analytics Laboratories, Inc. | 10/28/1983SE |
More from Bio-Analytics Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K831318 | Compur* M1100 Hematrcrit SystemJPI · Traditional | 06/08/1983SE |
| 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* M1000 Hemoglobin & Erythrocyte cleared by the FDA?
Compur* M1000 Hemoglobin & Erythrocyte (K833708) received a 510(k) decision of Substantially Equivalent on January 4, 1984, 76 days after the submission was received.
What is the product code of K833708?
The FDA product code is LKZ – Red-Cell Count By Photometry, a Class II (moderate risk) device regulated under 21 CFR 864.7100.