ACCESS FERRITIN ASSAY
FDA 510(k) clearance K926221 · decided 1993-01-13
Clearance details
- K-number
- K926221
- Device name
- ACCESS FERRITIN ASSAY
- Applicant
- Bio-Rad Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-12-10
- Decision date
- 1993-01-13
- Days to decision
- 34 days
- Clearance type
- Traditional
- Product code
- JMG
- Device class
- 2
- Regulation number
- 866.5340
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Chaska, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Access Ferritin (K234052) | Beckman Coulter, Inc. | 2024-03-20 |
| FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020 (K052082) | Beckman Coulter, Inc. | 2005-08-19 |
| TINA-QUANT FERRITIN ASSAY (K964282) | Boehringer Mannheim Corp. | 1997-07-30 |
| ELECSYS FERRITIN (K971833) | Boehringer Mannheim Corp. | 1997-06-02 |
| FERR FLEX REAGENT CARTRIDGE (K963498) | Dade Chemistry Systems, Inc. | 1997-01-24 |
| ACE(TM) CEDIA(R) FERRITIN ASSAY (K950393) | Schiapparelli Biosystems, Inc. | 1995-05-16 |
| IMMULITE FERRITIN (K925848) | Diagnostic Products Corp. | 1993-01-13 |
| COBAS CORE FERRITIN EIA (K920829) | Roche Diagnostic Systems, Inc. | 1992-06-19 |
| CEDIA FERRITIN ASSAY (K920318) | Microgenics Corp. | 1992-06-04 |
| MILENIA (TM) FERRITIN (K902997) | Diagnostic Products Corp. | 1990-08-02 |
| RIA-GNOST FERRITIN (K890697) | Cambridge Medical Technology | 1989-03-16 |
| CLINICAL ASSAYS GAMMACOAT [125I] FERRITIN IMMUNO. (K881138) | Baxter Healthcare Corp | 1988-04-21 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Access Ferritin Calibrators, Part No. 33025, Ref No. B50136C recall (Z-1833-2017) | Beckman Coulter Inc. | 2017-04-17 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| MONOLISA ANTI-HBC IGM EIA (P060034/S008) | Bio-Rad Laboratories, Inc. | 2014-03-19 |
| BIO-RAD MONOLISA ANTI-HBC IGM EIA (P060034/S007) | Bio-Rad Laboratories, Inc. | 2013-12-12 |
| BIO-RAD MONOLISA ANTI-HBC EIA (P060031/S007) | Bio-Rad Laboratories, Inc. | 2013-12-12 |
| BIO-RAD MONOLISA ANTI-HBC EIA (P060031/S006) | Bio-Rad Laboratories, Inc. | 2012-11-13 |
| BIO-RAD MONOLISA ANTI-HBC IGM EIA (P060034/S006) | Bio-Rad Laboratories, Inc. | 2012-11-13 |
| BIO-RAD MONOLISA ANTI-HBC EIA (P060031/S005) | Bio-Rad Laboratories, Inc. | 2011-04-28 |
| BIO-RAD MONOLISA ANTI-HBC EIA (P060031/S003) | Bio-Rad Laboratories, Inc. | 2010-12-30 |
| MONOLISA ANTI-HBC IGM EIA (P060034/S005) | Bio-Rad Laboratories, Inc. | 2010-11-23 |