Helena Sickle-Thal Quik Column Method
FDA 510(k) K812077 · Helena Laboratories
510(k) numberK812077
Submission
- Device name
- Helena Sickle-Thal Quik Column Method
- Applicant
- Helena Laboratories
Mchenry, IL, US - Received
- July 22, 1981
- Decision date
- August 18, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JPD – Hemoglobin A2 Quantitation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7400
- Specialty
- Hematology
Other 510(k)s with product code JPD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K020489 | G7 Automated HPLC Analyzer, Beta-Thalassemia ModeJPD · Traditional | Tosoh Medics, Inc. | 05/14/2002SE |
| K991127 | Variant II B-ThalassemiaJPD · Special | Bio-Rad | 06/10/1999SE |
| K924122 | Variant Beta-Thalassemia Short ProgramJPD · Traditional | Bio-Rad | 03/11/1993SE |
| K924496 | Glycomat Green HBA2 Estimation Reagent KitJPD · Traditional | Drew Scientific , Ltd. | 11/16/1992SE |
| K923318 | Columnmate Beta-Thal HBA2 Control - NormalJPD · Traditional | Helena Laboratories | 08/25/1992SE |
| K923317 | Columnmate Beta Thal HBA2 Control-AbnormalJPD · Traditional | Helena Laboratories | 08/25/1992SE |
| K913384 | Columnmate(Tm) Beta-Thal Cat. No. 4515JPD · Traditional | Helena Laboratories | 12/17/1991SE |
| K896168 | Hemoglobin A2 Micro Column TestJPD · Traditional | Bio-Rad | 01/18/1990SE |
| K875102 | Deter. of Hemoglobin A2 Using the DiamatJPD · Traditional | Bio-Rad | 02/24/1988SE |
| K823870 | Beta Thalquik Column #5341JPD · Traditional | Helena Laboratories | 02/01/1983SE |
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| K061014 | Actalyke QC Kit, Models Aqc-Hp and Aqc-LpJPA · Special | 05/10/2006SE |
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Questions and answers
When was Helena Sickle-Thal Quik Column Method cleared by the FDA?
Helena Sickle-Thal Quik Column Method (K812077) received a 510(k) decision of Substantially Equivalent on August 18, 1981, 27 days after the submission was received.
What is the product code of K812077?
The FDA product code is JPD – Hemoglobin A2 Quantitation, a Class II (moderate risk) device regulated under 21 CFR 864.7400.