Crestat Diagnostics, Inc.
Portland, OR, US
Crestat Diagnostics, Inc. appears in FDA device records in Portland, OR. FDA records list 29 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 29
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 29 510(k) clearances for Crestat Diagnostics, Inc. between 1990 and 1998. The busiest year on record is 1997, with 15. The most recent is 1998, with 5.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1990 | 1 |
| 1991 | 1 |
| 1992 | 1 |
| 1993 | 1 |
| 1994 | 5 |
| 1997 | 15 |
| 1998 | 5 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K980883 | N-ASSAY GLU-UL | CFR | Substantially Equivalent | |
| K981276 | N-ASSAY L D-BIL | CIG | Substantially Equivalent | |
| K981289 | N-ASSAY L T-BIL | CIG | Substantially Equivalent | |
| K980902 | N-ASSAY L AST/GOT | CIT | Substantially Equivalent | |
| K980900 | N-ASSAY CPK-L | CGS | Substantially Equivalent | |
| K972257 | N-ASSAY TIA ANTITHROMBIN III TEST KIT | DDQ | Substantially Equivalent | |
| K971985 | N-ASSAY TIA PLASMINOGEN TEST KIT | GGP | Substantially Equivalent | |
| K964296 | N-ASSAY TIA APO B TEST KIT | DER | Substantially Equivalent | |
| K964294 | N-ASSAY TIA APO A1/B MULTI CALIBRATOR | DER | Substantially Equivalent | |
| K964292 | N-ASSAY TIA APO A1 TEST KIT | DER | Substantially Equivalent | |
| K965100 | N-ASSAY TIA ALPHA-1-ANTITRYPSIN TEST KIT | DEM | Substantially Equivalent | |
| K965024 | N-ASSAY TIA C1-INACTIVATOR TEST KIT | DBA | Substantially Equivalent | |
| K964301 | N-ASSAY TIA MULTI V-NL | DAD | Substantially Equivalent | |
| K964300 | N-ASSAY TIA MULTI V-NL | DBI | Substantially Equivalent | |
| K964299 | N-ASSAY TIA MULTI V-NL | LKL | Substantially Equivalent | |
| K964298 | N-ASSAY TIA MULTI V-NL | CZW | Substantially Equivalent | |
| K964297 | N-ASSAY TIA C4 TEST KIT | DBI | Substantially Equivalent | |
| K965110 | N-ASSAY TIA MULTI CRP CALIBRATOR SET | DCK | Substantially Equivalent | |
| K964295 | N-ASSAY TIA TRANSFERRIN TEST KIT | DDG | Substantially Equivalent | |
| K965113 | N-ASSAY TIA FIBRINOGEN TEST KIT | KQJ | Substantially Equivalent | |
| K933972 | N-ASSAY TIA IGG | CFF | Substantially Equivalent | |
| K933971 | N-ASSAY TIA IGA | CFN | Substantially Equivalent | |
| K933970 | N-ASSAY TIA IGM | CFN | Substantially Equivalent | |
| K933973 | N-ASSAY TIA MULTI V-NL | CFN | Substantially Equivalent | |
| K934146 | N-ASSAY TIA MICROALBUMIN | JIR | Substantially Equivalent | |
| K934143 | N-ASSAY TIA MICROALBUMIN CALIBRATOR SET | JIX | Substantially Equivalent | |
| K914155 | TIA CRP TEST KIT | DCK | Substantially Equivalent | |
| K912148 | CHOLINESTERASE TEST KIT | DIH | Substantially Equivalent | |
| K902543 | ACID PHOSPHOTASE REAGENT TEST AND KIT | CKB | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CKBAcid Phosphatase, Naphthyl Phosphate
- LKLAlpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control
- DEMAlpha-1-Antitrypsin, Antigen, Antiserum, Control
- DERAlpha-1-Lipoprotein, Antigen, Antiserum, Control
- DDQAntigen, Antiserum, Control, Antithrombin Iii
- DCKC-Reactive Protein, Antigen, Antiserum, And Control
- JIXCalibrator, Multi-Analyte Mixture
- DIHColorimetry, Cholinesterase
- DBAComplement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control
- CZWComplement C3, Antigen, Antiserum, Control
- DBIComplement C4, Antigen, Antiserum, Control
- CIGDiazo Colorimetry, Bilirubin
- DADHaptoglobin, Antigen, Antiserum, Control
- CFRHexokinase, Glucose
- CFFImmunoelectrophoretic, Immunoglobulins, (G, A, M)
- JIRIndicator Method, Protein Or Albumin (Urinary, Non-Quant.)
- CFNMethod, Nephelometric, Immunoglobulins (G, A, M)
- CGSNad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
- CITNadh Oxidation/Nad Reduction, Ast/Sgot
- KQJSystem, Fibrinogen Determination
- GGPTest, Qualitative And Quantitative Factor Deficiency
- DDGTransferrin, Antigen, Antiserum, Control
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain