Hemocard Control Hb-Aa, Ae, Faa, Fae
FDA 510(k) K931234 · Isolab, Inc.
510(k) numberK931234
Submission
- Device name
- Hemocard Control Hb-Aa, Ae, Faa, Fae
- Applicant
- Isolab, Inc.
Akron, OH, US - Received
- March 10, 1993
- Decision date
- May 11, 1993
- 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
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|---|---|---|---|
| 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 |
| 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 |
| 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 |
|---|---|---|
| K951014 | Isolab's T4 Test KitKLI · Traditional | 10/18/1996SE |
| K950481 | Neonatal Chemistry System, Galactose Test KitJIA · Traditional | 02/01/1996SE |
| K943547 | Phenylalanine Test KitJNB · Traditional | 01/26/1996SE |
| K950803 | Isolab's GALACTOSE-1-PHOSPHATE Uridyl Tranferase Test Kits 800, 4000 SampleJJT · Traditional | 09/21/1995SE |
| K950415 | Fluoroscan NeonatalKHO · Traditional | 09/05/1995SE |
| K942276 | Quik-Sep Quantitative Hemoglobin S AssayGIQ · Traditional | 01/20/1995SE |
| K942222 | Quik-Sep Quantitive Hemoglobin S ControlsJCM · Traditional | 01/20/1995SE |
| K944185 | IsoscanJQT · Traditional | 11/17/1994SE |
| K934013 | Resolve Systems Alkaline Phosphatase Test KitCIN · Traditional | 04/26/1994SE |
| K923153 | Hemocard, Hemoglobin C AssayMLL · Traditional | 01/27/1994SE |
Questions and answers
When was Hemocard Control Hb-Aa, Ae, Faa, Fae cleared by the FDA?
Hemocard Control Hb-Aa, Ae, Faa, Fae (K931234) received a 510(k) decision of Substantially Equivalent on May 11, 1993, 62 days after the submission was received.
What is the product code of K931234?
The FDA product code is JCM – Control, Hemoglobin, Abnormal, a Class II (moderate risk) device regulated under 21 CFR 864.7415.