Casco Standards
Medical device manufacturer in Portland, ME.
38510(k) clearances
0PMA approvals
0recalls
Device types
- JJY Multi-Analyte Controls, All Kinds (Assayed) 15
- JJX Single (Specified) Analyte Controls… 10
- JIX Calibrator, Multi-Analyte Mixture 4
- JIT Calibrator, Secondary 3
- DIF Drug Mixture Control Materials 3
- JJT Enzyme Controls (Assayed And Unassayed) 1
- JJR Electrolyte Controls (Assayed And Unassayed) 1
- CDP Radioimmunoassay, Total Triiodothyronine 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K981436 | Document Ammonia/Ethanol/Lactate Calibrator, PN: M-109JIX · Special | 04/24/1998SE |
| K972904 | Document Molecular Pathology Chlamydia Trachomatis ControlJJY · Traditional | 02/20/1998SE |
| K962629 | Document Ammonia, Ethanol, Lactate CalibratorJIX · Traditional | 09/13/1996SE |
| K962630 | Document Ammonia, Ethanol, Lactate Assayed ControlJJY · Traditional | 07/22/1996SE |
| K961750 | Document Cardiac Assayed ControlJJY · Traditional | 07/22/1996SE |
| K960244 | Document TDM Ultra Assayed ControlDIF · Traditional | 03/22/1996SE |
| K955155 | Document TDM Ultra Unassayed ControlDIF · Traditional | 12/20/1995SE |
| K950469 | Document Serum Multianalyte Calibration Verification Test SetJJY · Traditional | 04/11/1995SE |
| K945718 | Document(R) HDL Cholesterol Calibration Verification Test SetJJX · Traditional | 01/17/1995SE |
| K945315 | Document(R) Ammonia/Ethanol Aqueous ControlJJY · Traditional | 12/09/1994SE |
| K944361 | Document R Ammonia/Ethanol ControlJJX · Traditional | 11/30/1994SE |
| K944639 | Documentr Ammonia/EthanolcalibratorJIX · Traditional | 11/15/1994SE |
| K944338 | Document R Ammonia / Ethanol Calibration Verification Rest SetJJX · Traditional | 11/15/1994SE |
| K940568 | Document(R) ZeroJJX · Traditional | 04/05/1994SE |
| K932870 | Document Chem IV Calibration Verification Test SetJJX · Traditional | 08/02/1993SE |
| K932458 | Document EnzymeJJY · Traditional | 06/29/1993SE |
| K931139 | Doculment(R) Chem Vi Calibration Verif Test SetJJY · Traditional | 05/12/1993SE |
| K924493 | Document Total and Direct Bilirubin Linearity-ModJJX · Traditional | 01/11/1993SE |
| K923821 | Document Chem V Calibration Verification Test SetJJX · Traditional | 11/05/1992SE |
| K923795 | Document Chem I Calibration Verification Test SetJJY · Traditional | 11/05/1992SE |
| K923794 | Document Chem II Calibration Verification Test SetJJX · Traditional | 11/05/1992SE |
| K923793 | Document Chem III Calibration Verification TestJJX · Traditional | 11/05/1992SE |
| K915792 | Document CK Isoenzymes ControlCDP · Traditional | 02/06/1992SE |
| K913309 | TDM I Linearity Test SetDIF · Traditional | 09/13/1991SE |
| K910440 | Document Reflectance II Linearity Test SetJJY · Traditional | 05/10/1991SE |
| K910962 | Cholesterol Calibrator SetJIT · Traditional | 03/29/1991SE |
| K901988 | Document(R) Reflectance I Linearity Test SetJJY · Traditional | 05/31/1990SE |
| K896522 | Document(Tm) Total and Direct Bilirubin LinearityJJY · Traditional | 01/02/1990SE |
| K893139 | Document(Tm) Uric Acid Linearity Test SetJIT · Traditional | 07/20/1989SE |
| K893142 | Document(Tm) Iron, Magnes, Trigly Linear Test SetJJY · Traditional | 06/23/1989SE |
| K893141 | Document(Tm) Iron Magnesium Linearity Test SetJJY · Traditional | 06/23/1989SE |
| K893140 | Document(Tm) Triglyceride Linearity Test SetJJX · Traditional | 06/23/1989SE |
| K884197 | Document(Tm) Cholesterol Calibrator SetJIT · Traditional | 12/14/1988SE |
| K883861 | Document(Tm) Protein/Cholesterol Linearity TestJJY · Traditional | 10/13/1988SE |
| K881773 | Document(Tm) Direct Ise Linearity Test SetJJR · Traditional | 06/10/1988SE |
| K870252 | Document(Tm) Multi-Analyte Linearity Test SetJJY · Traditional | 02/20/1987SE |
| K861506 | Document Enzyme Linearity Test SetsJJT · Traditional | 06/13/1986SE |
| K843947 | Doument TM Linearity Test StandardsJIX · Traditional | 10/17/1984SE |