Wash Solution Kit
FDA 510(k) K873130 · A-Kem, Inc.
510(k) numberK873130
Submission
- Device name
- Wash Solution Kit
- Applicant
- A-Kem, Inc.
Clifton, NJ, US - Received
- August 10, 1987
- Decision date
- October 23, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2160
- Specialty
- Clinical Chemistry
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More from Ortho-Clinical Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K884224 | Total Bilirubin Reagent Kit for Astra SystemsCIG · Traditional | 12/15/1988SE |
| K884227 | Calibrator Standard Kit for Astra SystemJIX · Traditional | 12/09/1988SE |
| K884226 | Amylase Reagent Kit for Astra SystemsCJA · Traditional | 12/09/1988SE |
| K884225 | Total Protein Reagent Kit for Astra SystemsCEK · Traditional | 12/09/1988SE |
| K882587 | A-Kem Albumin Reagent Kit for Astra SystemCIX · Traditional | 08/08/1988SE |
| K882586 | A-Kem Calcium Reagent Kit for Astra SystemCIC · Traditional | 08/08/1988SE |
| K873132 | Bun Reagent KitLFP · Traditional | 10/23/1987SE |
| K873131 | Creatinine Reagent KitCGX · Traditional | 10/23/1987SE |
| K873129 | Carbon Dioxide Reagent KitJFL · Traditional | 10/23/1987SE |
| K873128 | Glucose Reagent KitCGA · Traditional | 10/23/1987SE |
Questions and answers
When was Wash Solution Kit cleared by the FDA?
Wash Solution Kit (K873130) received a 510(k) decision of Substantially Equivalent on October 23, 1987, 74 days after the submission was received.
What is the product code of K873130?
The FDA product code is JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2160.