Auto Trol(Tm) Control, Levels 1 & 2 #16692 & 16693
FDA 510(k) K881229 · Em Diagnostic Systems, Inc.
510(k) numberK881229
Submission
- Device name
- Auto Trol(Tm) Control, Levels 1 & 2 #16692 & 16693
- Applicant
- Em Diagnostic Systems, Inc.
Gibbstown, NJ, US - Received
- March 22, 1988
- Decision date
- May 27, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JJY – Multi-Analyte Controls, All Kinds (Assayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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More from Aalto Scientific, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K935181 | Aspartate Aminotransferase (Ast) TestCIT · Traditional | 01/27/1994SE |
| K935180 | Alanine Aminotransferase (Alt) TestCKA · Traditional | 01/13/1994SE |
| K935179 | Emds Albumin (Alb) TestCIX · Traditional | 12/17/1993SE |
| K935178 | Emds Phosphorous (Phos) TestCEO · Traditional | 12/17/1993SE |
| K935177 | Gamma-Glutamyl Transferase (GGT) TestJQB · Traditional | 12/16/1993SE |
| K935176 | Iron TestJIY · Traditional | 12/16/1993SE |
| K935175 | Lactate Dehydrogenase (LD)CFJ · Traditional | 12/16/1993SE |
| K935174 | Total Protein Test (Tpro)CEK · Traditional | 12/16/1993SE |
| K935136 | Cholesterol (Chol) Test Item No. 65410CHH · Traditional | 12/16/1993SE |
| K935183 | Emds Magnesium (MG) TestJGJ · Traditional | 12/09/1993SE |
Questions and answers
When was Auto Trol(Tm) Control, Levels 1 & 2 #16692 & 16693 cleared by the FDA?
Auto Trol(Tm) Control, Levels 1 & 2 #16692 & 16693 (K881229) received a 510(k) decision of Substantially Equivalent on May 27, 1988, 66 days after the submission was received.
What is the product code of K881229?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.