Acs Colloid Osmotic Pressure Calibrator
FDA 510(k) K892213 · Analytical Control Systems, Inc.
510(k) numberK892213
Submission
- Device name
- Acs Colloid Osmotic Pressure Calibrator
- Applicant
- Analytical Control Systems, Inc.
Fishers, IN, US - Received
- April 3, 1989
- Decision date
- June 21, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JIW – Calibrator, Surrogate
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1150
- Specialty
- Clinical Chemistry
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| K882220 | Calibration KitJIW · Traditional | King Diagnostics, Inc. | 08/02/1988SE |
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| K854028 | Audit Automated Blood Chemistry AnalyzerJIW · Traditional | Verified Medical Research, Inc. | 12/02/1985SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K961892 | Specktin-La Test SetGFO · Traditional | 03/07/1997SE |
| K941115 | Acs Cardio-Trol ControlJJY · Traditional | 07/20/1994SE |
| K940272 | Acs Normal Angiotensin Converting Enzyme ControlJJX · Traditional | 04/20/1994SE |
| K940397 | Acs O Dilvent Protein Dilution MatrixJJY · Traditional | 03/11/1994SE |
| K930477 | Acs Angiotensin Converting Enzyme (Ace) CalibratorJIS · Traditional | 06/07/1993SE |
| K926012 | Acs Apct Reagent, ModifiedGFO · Traditional | 04/27/1993SE |
| K925340 | Coagulation Control Containing HemoglobinJPA · Traditional | 03/23/1993SE |
| K925906 | Normal Angiotensin Converting Enzyme ControlJJX · Traditional | 02/18/1993SE |
| K921223 | Acs Freeze-Dried Aptt ReagentGFO · Traditional | 08/18/1992SE |
| K921118 | Acs Apct ReagentGFO · Traditional | 07/28/1992SE |
Questions and answers
When was Acs Colloid Osmotic Pressure Calibrator cleared by the FDA?
Acs Colloid Osmotic Pressure Calibrator (K892213) received a 510(k) decision of Substantially Equivalent on June 21, 1989, 79 days after the submission was received.
What is the product code of K892213?
The FDA product code is JIW – Calibrator, Surrogate, a Class II (moderate risk) device regulated under 21 CFR 862.1150.