G7 Automated HPLC Analyzer, Beta-Thalassemia Mode
FDA 510(k) K020489 · Tosoh Medics, Inc.
510(k) numberK020489
Submission
- Device name
- G7 Automated HPLC Analyzer, Beta-Thalassemia Mode
- Applicant
- Tosoh Medics, Inc.
South San Francisco, CA, US - Received
- February 13, 2002
- Decision date
- May 14, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|---|
| 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 |
| K812077 | Helena Sickle-Thal Quik Column MethodJPD · Traditional | Helena Laboratories | 08/18/1981SE |
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| K992365 | Aia-Pack Folate AssayCGN · Traditional | 08/10/1999SE |
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| K991252 | Aia-Pack FT3 AssayCDP · Traditional | 05/11/1999SE |
Questions and answers
When was G7 Automated HPLC Analyzer, Beta-Thalassemia Mode cleared by the FDA?
G7 Automated HPLC Analyzer, Beta-Thalassemia Mode (K020489) received a 510(k) decision of Substantially Equivalent on May 14, 2002, 90 days after the submission was received.
What is the product code of K020489?
The FDA product code is JPD – Hemoglobin A2 Quantitation, a Class II (moderate risk) device regulated under 21 CFR 864.7400.