Document(Tm) Protein/Cholesterol Linearity Test
FDA 510(k) K883861 · Casco Standards
510(k) numberK883861
Submission
- Device name
- Document(Tm) Protein/Cholesterol Linearity Test
- Applicant
- Casco Standards
Yarmouth, ME, US - Received
- September 13, 1988
- Decision date
- October 13, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JJY – Multi-Analyte Controls, All Kinds (Assayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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| K150300 | Liquichek Cardiac Markers Plus Control LTJJY · Traditional | Bio-Rad Laboratories | 12/11/2015SE |
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| K143379 | Liquichek Maternal Serum II ControlJJY · Traditional | Bio-Rad Laboratories | 03/13/2015SE |
| K143573 | Audit MicroControls Linearity FD Tumor Markers IIJJY · Traditional | Aalto Scientific, Ltd. | 01/16/2015SE |
| K140971 | Liquid Assayed Chemistry Control Premium Plus Level 1,2 and Level 3.JJY · Traditional | Randox Laboratories Limited | 12/08/2014SE |
| K142978 | Audit MicroControls Linearity LQ Special DiabetesJJY · Traditional | Aalto Scientific, Ltd. | 11/20/2014SE |
More from Aalto Scientific, Ltd.
| 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 |
Questions and answers
When was Document(Tm) Protein/Cholesterol Linearity Test cleared by the FDA?
Document(Tm) Protein/Cholesterol Linearity Test (K883861) received a 510(k) decision of Substantially Equivalent on October 13, 1988, 30 days after the submission was received.
What is the product code of K883861?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.