Glycomat Green HBA2 Estimation Reagent Kit
FDA 510(k) K924496 · Drew Scientific , Ltd.
510(k) numberK924496
Submission
- Device name
- Glycomat Green HBA2 Estimation Reagent Kit
- Applicant
- Drew Scientific , Ltd.
London W4 4ph Uk, GB - Received
- September 4, 1992
- Decision date
- November 16, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| 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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| 510(k) | Device | Decision |
|---|---|---|
| K071562 | D3 Hematology Analyzer, Model D3GKZ · Traditional | 12/11/2007SE |
| K070704 | Trilogy AnalyzerCGA · Traditional | 07/13/2007SE |
| K060510 | Drew Scientific Glycated Hemoglobin Five Level Linearity KitJJX · Traditional | 06/19/2006SE |
| K043378 | Drew Scientific Ltd. Glycated Haemoglobin Two Level Calibrator KitJIT · Abbreviated | 12/29/2004SE |
| K012152 | DS30 Hcy Blood Collection TubesGIM · Traditional | 09/18/2001SE |
| K982003 | DS30 Hcy Homocysteine Assay KitLPS · Traditional | 02/11/1999SE |
| K933287 | 745 GlycomatLCP · Traditional | 09/09/1993SE |
| K920198 | Glycomat Haemoglobin AnalyserLCP · Traditional | 07/21/1992SE |
Questions and answers
When was Glycomat Green HBA2 Estimation Reagent Kit cleared by the FDA?
Glycomat Green HBA2 Estimation Reagent Kit (K924496) received a 510(k) decision of Substantially Equivalent on November 16, 1992, 73 days after the submission was received.
What is the product code of K924496?
The FDA product code is JPD – Hemoglobin A2 Quantitation, a Class II (moderate risk) device regulated under 21 CFR 864.7400.