Paragon Acid Hemoglobin Reagent Kit
FDA 510(k) K834595 · Beckman Instruments, Inc.
510(k) numberK834595
Submission
- Device name
- Paragon Acid Hemoglobin Reagent Kit
- Applicant
- Beckman Instruments, Inc.
Mchenry, IL, US - Received
- December 30, 1983
- Decision date
- May 7, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GKA – Abnormal Hemoglobin Quantitation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7415
- Specialty
- Hematology
Other 510(k)s with product code GKA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K232027 | CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS InstrumentGKA · Traditional | Sebia | 04/04/2024SE |
| K222635 | Premier Resolution SystemGKA · Traditional | Trinity Biotech (Primus Corporation, Dba Trinity… | 08/04/2023SE |
| K192931 | V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo ControlGKA · Traditional | Helena Laboratories, Corp. | 04/19/2022SE |
| K180762 | Capi 3 Hemoglobin(E)GKA · Traditional | Sebia | 12/14/2018SE |
| K171664 | Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview SoftwareGKA · Special | Bio-Rad Laboratories, Inc. | 09/13/2017SE |
| K112550 | Capillarys Hemoglobin, Capillarys Flex Piercing SystemGKA · Traditional | Sebia | 05/25/2012SE |
| K112491 | Sebia Capillarys Hemoglobin(E) with Capillarys 2GKA · Traditional | Sebia | 05/24/2012SE |
| K091283 | Capillarys Neonat HB (PN 2006)GKA · Traditional | Sebia | 02/22/2010SE |
| K082227 | Minicap Hemoglobin(E) Kit, Model 2207, 2227GKA · Traditional | Sebia | 03/26/2009SE |
| K080911 | Variant NBS Sickle Cell Program Reagent Kit, Variant NBS Newborn Screening System and…GKA · Special | Bio-Rad Laboratories Inc., Clinical Systems Divisi | 05/02/2008SE |
More from Bio-Rad Laboratories Inc., Clinical Systems Divisi
| 510(k) | Device | Decision |
|---|---|---|
| K973448 | Access Toxoplasma Igm Reagents on the Access Immunoassay Analyzer, Models 34460, 34465…LGD · Traditional | 09/17/1998SE |
| K982250 | Access Free T4 Reagents on the Access Immunoassay AnalyzerCEC · Traditional | 07/14/1998SE |
| K981403 | Immage Immunochemistry System Valproic Acid (Vpa) ReagentDKB · Traditional | 05/08/1998SE |
| K981354 | Access Afp Reagents on the Access Immunoassay Analyzer Model Number 33211LOJ · Traditional | 05/01/1998SE |
| K980173 | Access Total BHCG Reagents on the Access Immunoassay Analyzer; 33500, 33505JHI · Traditional | 03/18/1998SE |
| K974816 | Access(R) Psa Reagents on the Access(R) Immunoassay Analyzer 33220, 33225, 33229LTJ · Traditional | 02/20/1998SE |
| K974564 | Immage Immunochemistry System ALPHA-2-MACROGLOBULIN ReagentDEB · Traditional | 02/17/1998SE |
| K974110 | Immage Immunochemistry System Antithrombin III (AT3) ReagentJBQ · Traditional | 12/24/1997SE |
| K974452 | Vigil Lipid ControlJJY · Traditional | 12/17/1997SE |
| K973932 | Beckman Calibrator 2 (CAL2)JIX · Traditional | 12/15/1997SE |
Questions and answers
When was Paragon Acid Hemoglobin Reagent Kit cleared by the FDA?
Paragon Acid Hemoglobin Reagent Kit (K834595) received a 510(k) decision of Substantially Equivalent on May 7, 1984, 129 days after the submission was received.
What is the product code of K834595?
The FDA product code is GKA – Abnormal Hemoglobin Quantitation, a Class II (moderate risk) device regulated under 21 CFR 864.7415.