TINA-QUANT FERRITIN ASSAY
FDA 510(k) clearance K964282 · decided 1997-07-30
Clearance details
- K-number
- K964282
- Device name
- TINA-QUANT FERRITIN ASSAY
- Applicant
- Boehringer Mannheim Corp.
- Decision
- Substantially Equivalent
- Date received
- 1996-10-28
- Decision date
- 1997-07-30
- Days to decision
- 275 days
- Clearance type
- Traditional
- Product code
- JMG
- Device class
- 2
- Regulation number
- 866.5340
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Concord, CA, 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 |
| 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 |
| ACCESS FERRITIN ASSAY (K926221) | Bio-Rad Laboratories, Inc. | 1993-01-13 |
| 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
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ENZYMUN TEST{R} CEA (P860058/S001) | Boehringer Mannheim Corp. | 1993-07-29 |
| ENZYMUN-TEST{R} AFP (P860044/S003) | Boehringer Mannheim Corp. | 1991-09-03 |
| ENZYMUN-TEST{R} AFP (P860044/S002) | Boehringer Mannheim Corp. | 1991-07-19 |
| ENZYMUN-TEST{R} AFP (P860044/S001) | Boehringer Mannheim Corp. | 1990-08-03 |
| MICUR-MIC SYSTEMS (P820073) | Boehringer Mannheim Corp. | 1983-06-29 |