Document(Tm) Direct Ise Linearity Test Set
FDA 510(k) K881773 · Casco Standards
510(k) numberK881773
Submission
- Device name
- Document(Tm) Direct Ise Linearity Test Set
- Applicant
- Casco Standards
Yarmouth, ME, US - Received
- April 26, 1988
- Decision date
- June 10, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JJR – Electrolyte Controls (Assayed And Unassayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JJR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K990971 | Easylyte Quality Control Kit, Models 2814, 2815, 2816JJR · Traditional | Medica Corp. | 04/27/1999SE |
| K960592 | Electrolyte StandardsJJR · Traditional | Phoenix Diagnostics, Inc. | 05/13/1996SE |
| K955630 | RNA Medical Hemat ControlJJR · Traditional | Bionostics, Inc. | 03/01/1996SE |
| K951435 | Aalto Scientific Sweat Chloride Reference MaterialJJR · Traditional | Aalto Scientific, Ltd. | 05/02/1995SE |
| K943925 | Sweat Controls for Cystic Fibrosis TestingJJR · Traditional | Quantimetrix Corp. | 10/04/1994SE |
| K934641 | I-Stat Control Levels 1,2,3JJR · Traditional | I-Stat Corp. | 12/09/1993SE |
| K912513 | Electrolyte ControlJJR · Traditional | Verichem Laboratories, Inc. | 07/19/1991SE |
| K902266 | Electrolyte Controls (Assayed and Unassayed)JJR · Traditional | Phoenix Diagnostics, Inc. | 06/06/1990SE |
| K894576 | Ciba Corning Certain LyteJJR · Traditional | Ciba Corning Diagnostics Corp. | 10/30/1989SE |
| K895582 | Qclyte Protein-Based Ise ControlJJR · Traditional | Baxter Healthcare Corp | 10/04/1989SE |
More from Baxter Healthcare Corp
| 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) Direct Ise Linearity Test Set cleared by the FDA?
Document(Tm) Direct Ise Linearity Test Set (K881773) received a 510(k) decision of Substantially Equivalent on June 10, 1988, 45 days after the submission was received.
What is the product code of K881773?
The FDA product code is JJR – Electrolyte Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.