510(k) K926221
- Device
- ACCESS FERRITIN ASSAY
- Applicant
- BIO-RAD LABORATORIES, INC.
- 510(k) number
- K926221
- Product code
- JMG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-01-13
- Date received
- 1992-12-10
- Regulation
- 866.5340
- Classification name
- Radioimmunoassay (two-site Solid Phase), Ferritin
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JAN OLSEN
- Address
- 1000 Lake Hazeltine Dr. Chaska MN US 55318 55318
FDA Registration Numbers#
- 1063851
- 3004192065
- 3010825766
- 2032682
- 2517506
- 2020726
- 2432235
- 9610126
- 2050012
- 3011989923
- 9610806
- 3006198300
- 3009518015
- 1036362
- 3002806944
- 9680746
- 2122870
Source Documents#
Other 510(k) Records For Product Code JMG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K234052 | Access Ferritin | Beckman Coulter, Inc. | 2024-03-20 |
| K052082 | FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020 | Beckman Coulter, Inc. | 2005-08-19 |
| K964282 | TINA-QUANT FERRITIN ASSAY | Boehringer Mannheim Corp. | 1997-07-30 |
| K971833 | ELECSYS FERRITIN | Boehringer Mannheim Corp. | 1997-06-02 |
| K963498 | FERR FLEX REAGENT CARTRIDGE | Dade Chemistry Systems, Inc. | 1997-01-24 |
| K950393 | ACE(TM) CEDIA(R) FERRITIN ASSAY | Schiapparelli Biosystems, Inc. | 1995-05-16 |
| K925848 | IMMULITE FERRITIN | Diagnostic Products Corp. | 1993-01-13 |
| K920829 | COBAS CORE FERRITIN EIA | Roche Diagnostic Systems, Inc. | 1992-06-19 |
| K920318 | CEDIA FERRITIN ASSAY | Microgenics Corp. | 1992-06-04 |
| K902997 | MILENIA (TM) FERRITIN | Diagnostic Products Corp. | 1990-08-02 |
| K890697 | RIA-GNOST FERRITIN | Cambridge Medical Technology | 1989-03-16 |
| K881138 | CLINICAL ASSAYS GAMMACOAT [125I] FERRITIN IMMUNO. | Baxter Healthcare Corp | 1988-04-21 |
| K873730 | MEDIX BIOTECH FERRITIN ENZYME IMMUNOASSAY TEST KIT | Medix Biotech, Inc. | 1987-11-04 |
| K872955 | DELFIA(TM) FERRITIN KIT | Lkb Instruments, Inc. | 1987-08-21 |
| K840460 | CORNINGS MAGIC FERRITIN RADIOIMMUNO- | Corning Medical & Scientific | 1984-03-30 |
Legacy Summary#
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FDA Review#
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