Primus Variant System PVS99
FDA 510(k) K955283 · Primus Corp.
510(k) numberK955283
Submission
- Device name
- Primus Variant System PVS99
- Applicant
- Primus Corp.
Kansas City, MO, US - Received
- November 16, 1995
- Decision date
- March 1, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GKA – Abnormal Hemoglobin Quantitation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7415
- Specialty
- Hematology
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| 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 |
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| 510(k) | Device | Decision |
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| K062658 | Primus A1CARE AssayLCP · Traditional | 11/26/2007SE |
| K013787 | Nycocard CRPDCK · Traditional | 05/14/2002SE |
| K014084 | Nycocard CRP ControlDCK · Traditional | 01/07/2002SE |
| K993131 | Nycocard HBA1C Glycosylated Hemoglobin AssayLCP · Traditional | 05/22/2000SE |
| K994045 | Primus Liquid Calibrator for GHB/A1C Level 1 and Level 2LCP · Special | 12/21/1999SE |
| K992921 | Primus Liquid Control for Ghb/Alc Level I and Level IILCP · Traditional | 11/12/1999SE |
| K942009 | Primus Rapid Gel 100 Glycated Hemoglobin AssayLCP · Traditional | 09/14/1994SE |
| K940008 | Glycated Protein CalibratorsJIS · Traditional | 05/09/1994SE |
| K940142 | Glycated Protein ControlsJJX · Traditional | 04/26/1994SE |
| K936204 | Glycated Hemoglobin CalibratorsLCP · Traditional | 03/22/1994SE |
Questions and answers
When was Primus Variant System PVS99 cleared by the FDA?
Primus Variant System PVS99 (K955283) received a 510(k) decision of Substantially Equivalent on March 1, 1996, 106 days after the submission was received.
What is the product code of K955283?
The FDA product code is GKA – Abnormal Hemoglobin Quantitation, a Class II (moderate risk) device regulated under 21 CFR 864.7415.