510(k) K981931
- Device
- CEDIA RED BLOOD CELL FOLATE REAGENT PACK, CEDIA FOLATE ASSAY AND ELECSYS FOLATE ASSAY
- Applicant
- ROCHE DIAGNOSTICS/BOEHRINGER MANNHEIM GMBH
- 510(k) number
- K981931
- Product code
- CGN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-08-25
- Date received
- 1998-06-02
- Regulation
- 862.1295
- Classification name
- Acid, Folic, Radioimmunoassay
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Patricia M Klimley
- Address
- 4300 Hacienda Dr. Pleasanton CA US
FDA Registration Numbers#
- 3015969360
- 3005094123
- 3006198300
- 3006677029
- 9680746
- 2050012
- 3005333358
- 2432235
- 9610529
- 3012963943
- 2250051
- 3002809144
- 2182595
- 9612316
- 2020726
- 3009518015
- 1036362
- 2517506
- 2122870
- 8031673
- 3011989923
- 3033967997
- 3002642396
- 8020888
- 1219913
- 3005529799
- 3007111389
- 9610126
- 1319681
- 3000308930
- 3002806944
- 3005655287
- 2032839
- 3004192065
Source Documents#
Other 510(k) Records For Product Code CGN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K233060 | Elecsys Folate III | Roche Diagnostics | 2024-06-17 |
| K223590 | Access Folate Assay | Beckman Coulter, Inc. | 2023-08-23 |
| K192586 | LIAISON® Folate | DiaSorin, Inc. | 2020-05-06 |
| K172201 | Atellica IM Folate Assay | Siemens Healthcare Diagnostics, Inc. | 2018-04-12 |
| K161646 | Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set | Diazyme Laboratories | 2016-11-04 |
| K141426 | ELECSYS FOLATE III | Roche Diagnostics | 2014-10-17 |
| K103716 | ROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSET | Roche Diagnostics | 2011-05-12 |
| K092740 | ARCHITECT FOLATE REAGENTS, ARCHITECT FOLATE CALIBRATORS, AND ARCHITECT FOLATE CONTROLS, MODELS 1P74, 1P74, 1P74 | Abbott Laboratories | 2010-03-05 |
| K091332 | AIA-PACK RBC FOLATE | Tosoh Bioscience, Inc. | 2009-10-02 |
| K082340 | ROCHE ELECSYS FOLATE III, ROCHE ELECSYS RBC FOLATE HEMOLYSING REAGENT, ROCHE ELECSYS FOLATE III CALSET, ROCHE ELECSYS | Roche Diagnostics Corp. | 2009-06-19 |
| K060774 | FOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208 | Beckman Coulter, Inc. | 2006-04-21 |
| K051292 | ELECSYS RBC FOLATE HEMOLYZED REAGENT | Roche Diagnostics Corp. | 2005-06-17 |
| K043318 | MODIFICATION TO ROCHE ELECSYS FOLATE II IMMUNOASSAY | Roche Diagnostics Corp. | 2004-12-23 |
| K031756 | ROCHE DIAGNOSTICS ELECSYS FOLATE II ASSAY | Roche Diagnostics Corp. | 2003-06-25 |
| K023397 | ABBOTT ARCHITECT FOLATE | Abbott Laboratories | 2002-12-16 |
Legacy Summary#
summary
FDA Review#
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