Company ยท US
Reference Diagnostics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1990 to 2006. Name variants (Inc, Corp, punctuation) are merged.
17510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JIT | Calibrator, Secondary | 5 |
| MRR | System, Test, Low Density, Lipoprotein | 4 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 2 |
| JMO | Ferrozine (Colorimetric) Iron Binding Capacity | 2 |
| LBR | Ldl & Vldl Precipitation, Hdl | 2 |
| DBF | Ferritin, Antigen, Antiserum, Control | 1 |
| LBS | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 13, 2006 | K053291 | FERRITIN CALIBRATOR SET, CATALOG NO. 8203 Reference Diagnostics, Inc. | JIT |
| Mar 13, 2006 | K053211 | RDI HSFERRITIN KIT Reference Diagnostics, Inc. | DBF |
| Nov 9, 2005 | K052148 | TOTAL IRON-BINDING CAPACITY CALIBRATOR SET. DIRECT TIBC CALIBRATOR SET Reference Diagnostics, Inc. | JIT |
| Sep 30, 2003 | K030044 | EXTENDED RANGE HS CRP KIT, CAT NO:9200 Reference Diagnostics, Inc. | DCK |
| Apr 11, 2003 | K030772 | RDI EXTENDED RANGE CRP CALIBRATOR SET Reference Diagnostics, Inc. | JIT |
| Jun 27, 2002 | K021609 | RDI HS CRP KIT Reference Diagnostics, Inc. | DCK |
| Jun 27, 2002 | K021607 | RDI HS CRP CALIBRATOR SET Reference Diagnostics, Inc. | JIT |
| May 4, 2000 | K000783 | DIRECT TIBC CALIBRATOR Reference Diagnostics, Inc. | JIT |
| May 2, 2000 | K000781 | DIRECT TIBC KIT Reference Diagnostics, Inc. | JMO |
| Feb 16, 1999 | K990216 | MAGNETIC TIBC KIT Reference Diagnostics, Inc. | JMO |
| Jan 28, 1999 | K984107 | RDI DIRECT LDL CHOLESTEROL TEST Reference Diagnostics, Inc. | MRR |
| Dec 22, 1997 | K973988 | RDI HOMOGENEOUS HDL CHOLESTEROL TEST Reference Diagnostics, Inc. | LBS |
| Nov 20, 1996 | K964064 | RDI LIPIDIRECT MAGNETIC LDL REAGENT Reference Diagnostics, Inc. | MRR |
| Nov 20, 1996 | K964063 | RDI LDL PRECIPITATION REAGENT Reference Diagnostics, Inc. | MRR |
| Aug 2, 1995 | K944975 | MAGNETIC HDL CHOLESTEROL TEST Reference Diagnostics, Inc. | LBR |
| Jul 18, 1991 | K911906 | MAGNETIC HDL CHOLESTEROL TEST Reference Diagnostics, Inc. | LBR |
| Mar 19, 1990 | K893740 | LIPIDIRECT LOW DENSITY LIPOPROTEIN CHOLESTEROL TES Reference Diagnostics, Inc. | MRR |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||