Sickle Hemoglobin (Hba/S) Control Set
FDA 510(k) K913427 · Creative Laboratory Products, Inc.
510(k) numberK913427
Submission
- Device name
- Sickle Hemoglobin (Hba/S) Control Set
- Applicant
- Creative Laboratory Products, Inc.
Indianapolis, IN, US - Received
- August 1, 1991
- Decision date
- November 19, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JCM – Control, Hemoglobin, Abnormal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7415
- Specialty
- Hematology
Other 510(k)s with product code JCM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K053031 | Extendsure Hbfasc ControlJCM · Traditional | Cantebury Scientific , Ltd. | 12/07/2005SE |
| K011389 | Hemoglobin F & A2 Control (Beta-Thalassaemia Control)JCM · Traditional | Canterbury Health Laboratories | 06/21/2001SE |
| K983704 | Modification to Abuscreen Online for PhencyclidineJCM · Traditional | Roche Diagnostic Systems, Inc. | 02/10/1999SE |
| K942222 | Quik-Sep Quantitive Hemoglobin S ControlsJCM · Traditional | Isolab, Inc. | 01/20/1995SE |
| K933086 | Afsc Hemo Control #5331, AA2 Hemo Control #5328JCM · Traditional | Helena Laboratories | 10/31/1994SE |
| K931234 | Hemocard Control Hb-Aa, Ae, Faa, FaeJCM · Traditional | Isolab, Inc. | 05/11/1993SE |
| K924173 | Hemocard(Tm) ControlJCM · Traditional | Isolab, Inc. | 12/01/1992SE |
| K911347 | Lyphochek(R) Hemoglobin A2 ControlJCM · Traditional | Bio-Rad | 06/10/1991SE |
| K910431 | Hemocard ControlJCM · Traditional | Isolab, Inc. | 03/11/1991SE |
| K820787 | Helena Abnormal HBA2 Quik Column ControlJCM · Traditional | Helena Laboratories | 04/08/1982SE |
More from Helena Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K950589 | CLP High Level High Density Lipo Protein Cholesterol Control-HlJJX · Traditional | 03/20/1995SE |
| K942284 | CLP Total Iron and Uibc/Tibc Linearity Control SetJJX · Traditional | 08/26/1994SE |
| K922995 | Lipid ControlsJJX · Traditional | 08/12/1992SE |
| K913371 | Total Iron and Unsat Iron Bind Capac/Iron Bind CalJIT · Traditional | 11/08/1991SE |
| K913585 | Lipase Linearity ControlJJX · Traditional | 10/21/1991SE |
| K913224 | Lipid Linearity ControlsJJY · Traditional | 09/25/1991SE |
| K913496 | Cholinesterase Linearity ControlJJX · Traditional | 09/11/1991SE |
| K912823 | High Density Lipoprotein CholesterolLBR · Traditional | 08/16/1991SE |
| K912725 | Total Iron & Unsat Iron Bind Cap/Iron Bind ControlJJY · Traditional | 07/30/1991SE |
| K904989 | CLP Low Level HDL Cholesterol-Lipid Control-IiJJY · Traditional | 01/23/1991SE |
Questions and answers
When was Sickle Hemoglobin (Hba/S) Control Set cleared by the FDA?
Sickle Hemoglobin (Hba/S) Control Set (K913427) received a 510(k) decision of Substantially Equivalent on November 19, 1991, 110 days after the submission was received.
What is the product code of K913427?
The FDA product code is JCM – Control, Hemoglobin, Abnormal, a Class II (moderate risk) device regulated under 21 CFR 864.7415.