Erythrocyte Test
FDA 510(k) K832771 · Bio-Analytics Laboratories, Inc.
510(k) numberK832771
Submission
- Device name
- Erythrocyte Test
- Applicant
- Bio-Analytics Laboratories, Inc.
Mchenry, IL, US - Received
- August 16, 1983
- Decision date
- October 28, 1983
- 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 |
|---|---|---|---|
| K833708 | Compur* M1000 Hemoglobin & ErythrocyteLKZ · Traditional | Worthington Diagnostic Systems | 01/04/1984SE |
More from Worthington Diagnostic Systems
| 510(k) | Device | Decision |
|---|---|---|
| K861638 | Kinetic Alkaline Phosphatase Reagent KitCJE · Traditional | 05/29/1986SE |
| K860245 | Enzymatic Alpha-Amylase Reagent KitJFJ · Traditional | 03/14/1986SE |
| K860213 | Albumin Reagent KitCIX · Traditional | 02/11/1986SE |
| K851514 | Ultra-Violet Glucose ReagentCFA · Traditional | 05/20/1985SE |
| K851513 | Ultra-Violet Bun Reagent KitCDQ · Traditional | 05/20/1985SE |
| K850639 | Enzymatic Alpha-Amylase Reagent KitCIW · Traditional | 03/05/1985SE |
| K832567 | Acetaminophen(ParacetamolLDP · Traditional | 09/12/1983SE |
| K831414 | Colorimetric BunCDL · Traditional | 06/16/1983SE |
| K821934 | Bio-Cal Operation Check KitJIS · Traditional | 07/20/1982SE |
| K813431 | SalicylatesDKJ · Traditional | 03/25/1982SE |
Questions and answers
When was Erythrocyte Test cleared by the FDA?
Erythrocyte Test (K832771) received a 510(k) decision of Substantially Equivalent on October 28, 1983, 73 days after the submission was received.
What is the product code of K832771?
The FDA product code is LKZ – Red-Cell Count By Photometry, a Class II (moderate risk) device regulated under 21 CFR 864.7100.