Deter. of Hemoglobin A2 Using the Diamat
FDA 510(k) K875102 · Bio-Rad
510(k) numberK875102
Submission
- Device name
- Deter. of Hemoglobin A2 Using the Diamat
- Applicant
- Bio-Rad
Hercules, CA, US - Received
- December 10, 1987
- Decision date
- February 24, 1988
- 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
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|---|---|---|---|
| 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 |
| 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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Questions and answers
When was Deter. of Hemoglobin A2 Using the Diamat cleared by the FDA?
Deter. of Hemoglobin A2 Using the Diamat (K875102) received a 510(k) decision of Substantially Equivalent on February 24, 1988, 76 days after the submission was received.
What is the product code of K875102?
The FDA product code is JPD – Hemoglobin A2 Quantitation, a Class II (moderate risk) device regulated under 21 CFR 864.7400.