Afsc Hemo Control #5331, AA2 Hemo Control #5328
FDA 510(k) K933086 · Helena Laboratories
510(k) numberK933086
Submission
- Device name
- Afsc Hemo Control #5331, AA2 Hemo Control #5328
- Applicant
- Helena Laboratories
Beaumont, TX, US - Received
- June 23, 1993
- Decision date
- October 31, 1994
- 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 |
| 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 |
| 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 |
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| K100103 | Specialty Assayed CONTROL-2GGC · Traditional | 12/15/2010SE |
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| K061014 | Actalyke QC Kit, Models Aqc-Hp and Aqc-LpJPA · Special | 05/10/2006SE |
| K050053 | Hemoram/Aggram AnalyzerJPA · Traditional | 07/11/2005SE |
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Questions and answers
When was Afsc Hemo Control #5331, AA2 Hemo Control #5328 cleared by the FDA?
Afsc Hemo Control #5331, AA2 Hemo Control #5328 (K933086) received a 510(k) decision of Substantially Equivalent on October 31, 1994, 495 days after the submission was received.
What is the product code of K933086?
The FDA product code is JCM – Control, Hemoglobin, Abnormal, a Class II (moderate risk) device regulated under 21 CFR 864.7415.