Lithium Internal Standard 3000 Meq/L #60084
FDA 510(k) K871187 · In Vitro Diagnostics, Inc.
510(k) numberK871187
Submission
- Device name
- Lithium Internal Standard 3000 Meq/L #60084
- Applicant
- In Vitro Diagnostics, Inc.
Shelton, CT, US - Received
- March 24, 1987
- Decision date
- May 28, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JIS – Calibrator, Primary
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1150
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JIS
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|---|---|---|---|
| K122126 | Direct Ldl/Hdl Cholesterol CalibratorJIS · Traditional | Randox Laboratories Limited | 08/14/2012SE |
| K061251 | Dimension Vista Total Iron Binding Capacity CalibratorJIS · Traditional | Dade Behring, Inc. | 05/31/2006SE |
| K060266 | Dimension Iron CalibratorJIS · Traditional | Dade Behring, Inc. | 03/09/2006SE |
| K053104 | Dimension Cardiophase High Sensitivity C-Reactive Protein CalibratorJIS · Traditional | Dade Behring, Inc. | 12/23/2005SE |
| K032697 | Dimension Total Triiodothyronine Calibrator (RC414)JIS · Traditional | Dade Behring, Inc. | 11/07/2003SE |
| K032608 | Gonotec Calibration Solution 300 Mosmol/Kg for OsmometerJIS · Abbreviated | Gonotec Gesellschaft Fuer Mess-Und Regeltechnik MB | 10/21/2003SE |
| K032296 | Vitros Immunodiagnostic Products Progestrone Reagent Pack and CalibratorsJIS · Special | Ortho-Clinical Diagnostics, Inc. | 08/13/2003SE |
| K030964 | Calibration Plasma LMW HeparinJIS · Traditional | Instrumentation Laboratory CO | 06/06/2003SE |
| K030546 | CRP (II) CalibratorsJIS · Traditional | Denka Seiken Co., Ltd. | 06/02/2003SE |
| K030320 | Wako Autokit Micro Albumin, Wako Autokit Micro Calibrator Set, Micro Albumin Control SetJIS · Traditional | Wako Chemicals USA, Inc. | 04/11/2003SE |
More from Wako Chemicals USA, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K896867 | Thyroid Stimulating Hormone-Eia-XtJLW · Traditional | 02/23/1990SE |
| K896866 | Luteinizing Hormone-Eia-XtCEP · Traditional | 02/13/1990SE |
| K896863 | Digoxin-Eia-XtKXT · Traditional | 02/13/1990SE |
| K896865 | Vitro T4-EIA-XTKLI · Traditional | 01/30/1990SE |
| K896925 | T Uptake Enzyme Immunoassay Crimped Tube KitKHQ · Traditional | 01/18/1990SE |
| K896864 | Follicle Stimulating Hormone-Eia-XtCGJ · Traditional | 01/11/1990SE |
| K873832 | Reagents for Use on Contraves DC300, DC500, AL801KRZ · Traditional | 11/23/1987SE |
| K871188 | Lithium Internal Standard 1500 Meq/L #60086JIS · Traditional | 05/28/1987SE |
| K871186 | Cesium Diluent 1.5 Mmol Cs/L #60087JIS · Traditional | 05/28/1987SE |
| K871185 | Lithium Internal Standard 1 Meq/L #60085JIS · Traditional | 05/28/1987SE |
Questions and answers
When was Lithium Internal Standard 3000 Meq/L #60084 cleared by the FDA?
Lithium Internal Standard 3000 Meq/L #60084 (K871187) received a 510(k) decision of Substantially Equivalent on May 28, 1987, 65 days after the submission was received.
What is the product code of K871187?
The FDA product code is JIS – Calibrator, Primary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.