Document(Tm) Iron Magnesium Linearity Test Set
FDA 510(k) K893141 · Casco Standards
510(k) numberK893141
Submission
- Device name
- Document(Tm) Iron Magnesium Linearity Test Set
- Applicant
- Casco Standards
Yarmouth, ME, US - Received
- April 25, 1989
- Decision date
- June 23, 1989
- 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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| 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) Iron Magnesium Linearity Test Set cleared by the FDA?
Document(Tm) Iron Magnesium Linearity Test Set (K893141) received a 510(k) decision of Substantially Equivalent on June 23, 1989, 59 days after the submission was received.
What is the product code of K893141?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.