Lyphochek(R) Hemoglobin A2 Control
FDA 510(k) K911347 · Bio-Rad
510(k) numberK911347
Submission
- Device name
- Lyphochek(R) Hemoglobin A2 Control
- Applicant
- Bio-Rad
Hercules, CA, US - Received
- March 27, 1991
- Decision date
- June 10, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K913427 | Sickle Hemoglobin (Hba/S) Control SetJCM · Traditional | Creative Laboratory Products, Inc. | 11/19/1991SE |
| K910431 | Hemocard ControlJCM · Traditional | Isolab, Inc. | 03/11/1991SE |
| K820787 | Helena Abnormal HBA2 Quik Column ControlJCM · Traditional | Helena Laboratories | 04/08/1982SE |
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Questions and answers
When was Lyphochek(R) Hemoglobin A2 Control cleared by the FDA?
Lyphochek(R) Hemoglobin A2 Control (K911347) received a 510(k) decision of Substantially Equivalent on June 10, 1991, 75 days after the submission was received.
What is the product code of K911347?
The FDA product code is JCM – Control, Hemoglobin, Abnormal, a Class II (moderate risk) device regulated under 21 CFR 864.7415.