Cesium Diluent 1.5 Mmol Cs/L #60087
FDA 510(k) K871186 · In Vitro Diagnostics, Inc.
510(k) numberK871186
Submission
- Device name
- Cesium Diluent 1.5 Mmol Cs/L #60087
- 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
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| 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 |
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| 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 |
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| K871185 | Lithium Internal Standard 1 Meq/L #60085JIS · Traditional | 05/28/1987SE |
Questions and answers
When was Cesium Diluent 1.5 Mmol Cs/L #60087 cleared by the FDA?
Cesium Diluent 1.5 Mmol Cs/L #60087 (K871186) 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 K871186?
The FDA product code is JIS – Calibrator, Primary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.