Company ยท US
Crestat Diagnostics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1990 to 1998. Name variants (Inc, Corp, punctuation) are merged.
29510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CFN | Method, Nephelometric, Immunoglobulins (G, A, M) | 3 |
| DER | Alpha-1-Lipoprotein, Antigen, Antiserum, Control | 3 |
| CIG | Diazo Colorimetry, Bilirubin | 2 |
| DBI | Complement C4, Antigen, Antiserum, Control | 2 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 2 |
| CFF | Immunoelectrophoretic, Immunoglobulins, (G, A, M) | 1 |
| CFR | Hexokinase, Glucose | 1 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 1 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 1 |
| CKB | Acid Phosphatase, Naphthyl Phosphate | 1 |
| CZW | Complement C3, Antigen, Antiserum, Control | 1 |
| DAD | Haptoglobin, Antigen, Antiserum, Control | 1 |
| DBA | Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control | 1 |
| DDG | Transferrin, Antigen, Antiserum, Control | 1 |
| DDQ | Antigen, Antiserum, Control, Antithrombin Iii | 1 |
| DEM | Alpha-1-Antitrypsin, Antigen, Antiserum, Control | 1 |
| DIH | Colorimetry, Cholinesterase | 1 |
| GGP | Test, Qualitative And Quantitative Factor Deficiency | 1 |
| JIR | Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | 1 |
| JIX | Calibrator, Multi-Analyte Mixture | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 3, 1998 | K980883 | N-ASSAY GLU-UL Crestat Diagnostics, Inc. | CFR |
| May 1, 1998 | K981276 | N-ASSAY L D-BIL Crestat Diagnostics, Inc. | CIG |
| Apr 27, 1998 | K981289 | N-ASSAY L T-BIL Crestat Diagnostics, Inc. | CIG |
| Mar 26, 1998 | K980902 | N-ASSAY L AST/GOT Crestat Diagnostics, Inc. | CIT |
| Mar 26, 1998 | K980900 | N-ASSAY CPK-L Crestat Diagnostics, Inc. | CGS |
| Oct 20, 1997 | K972257 | N-ASSAY TIA ANTITHROMBIN III TEST KIT Crestat Diagnostics, Inc. | DDQ |
| Oct 20, 1997 | K971985 | N-ASSAY TIA PLASMINOGEN TEST KIT Crestat Diagnostics, Inc. | GGP |
| Aug 1, 1997 | K964296 | N-ASSAY TIA APO B TEST KIT Crestat Diagnostics, Inc. | DER |
| Aug 1, 1997 | K964294 | N-ASSAY TIA APO A1/B MULTI CALIBRATOR Crestat Diagnostics, Inc. | DER |
| Aug 1, 1997 | K964292 | N-ASSAY TIA APO A1 TEST KIT Crestat Diagnostics, Inc. | DER |
| Jul 14, 1997 | K965100 | N-ASSAY TIA ALPHA-1-ANTITRYPSIN TEST KIT Crestat Diagnostics, Inc. | DEM |
| Jul 14, 1997 | K965024 | N-ASSAY TIA C1-INACTIVATOR TEST KIT Crestat Diagnostics, Inc. | DBA |
| Jul 14, 1997 | K964301 | N-ASSAY TIA MULTI V-NL Crestat Diagnostics, Inc. | DAD |
| Jul 14, 1997 | K964300 | N-ASSAY TIA MULTI V-NL Crestat Diagnostics, Inc. | DBI |
| Jul 14, 1997 | K964299 | N-ASSAY TIA MULTI V-NL Crestat Diagnostics, Inc. | LKL |
| Jul 14, 1997 | K964298 | N-ASSAY TIA MULTI V-NL Crestat Diagnostics, Inc. | CZW |
| Jul 14, 1997 | K964297 | N-ASSAY TIA C4 TEST KIT Crestat Diagnostics, Inc. | DBI |
| Jul 3, 1997 | K965110 | N-ASSAY TIA MULTI CRP CALIBRATOR SET Crestat Diagnostics, Inc. | DCK |
| Jun 16, 1997 | K964295 | N-ASSAY TIA TRANSFERRIN TEST KIT Crestat Diagnostics, Inc. | DDG |
| Apr 16, 1997 | K965113 | N-ASSAY TIA FIBRINOGEN TEST KIT Crestat Diagnostics, Inc. | KQJ |
| Mar 22, 1994 | K933972 | N-ASSAY TIA IGG Crestat Diagnostics, Inc. | CFF |
| Mar 22, 1994 | K933971 | N-ASSAY TIA IGA Crestat Diagnostics, Inc. | CFN |
| Mar 22, 1994 | K933970 | N-ASSAY TIA IGM Crestat Diagnostics, Inc. | CFN |
| Jan 28, 1994 | K933973 | N-ASSAY TIA MULTI V-NL Crestat Diagnostics, Inc. | CFN |
| Jan 11, 1994 | K934146 | N-ASSAY TIA MICROALBUMIN Crestat Diagnostics, Inc. | JIR |
| Nov 5, 1993 | K934143 | N-ASSAY TIA MICROALBUMIN CALIBRATOR SET Crestat Diagnostics, Inc. | JIX |
| Jan 15, 1992 | K914155 | TIA CRP TEST KIT Crestat Diagnostics, Inc. | DCK |
| Aug 12, 1991 | K912148 | CHOLINESTERASE TEST KIT Crestat Diagnostics, Inc. | DIH |
| Sep 7, 1990 | K902543 | ACID PHOSPHOTASE REAGENT TEST AND KIT Crestat Diagnostics, Inc. | CKB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||