Easy-Test Amylase (Amyl), Item Number 19019
FDA 510(k) K874705 · Em Diagnostic Systems, Inc.
510(k) numberK874705
Submission
- Device name
- Easy-Test Amylase (Amyl), Item Number 19019
- Applicant
- Em Diagnostic Systems, Inc.
Gibbstown, NJ, US - Received
- November 19, 1987
- Decision date
- December 22, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JEJ – Tubing, Instrumentation, Bronchoscope (Brush Sheath A/O Aspirating)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.4680
- Specialty
- Ear, Nose, Throat
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Other 510(k)s with product code JEJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K821514 | Technicon RA-1000 Sys, Analytes IIIJEJ · Traditional | Technicon Instruments Corp. | 05/10/1982SE |
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|---|---|---|
| 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 Easy-Test Amylase (Amyl), Item Number 19019 cleared by the FDA?
Easy-Test Amylase (Amyl), Item Number 19019 (K874705) received a 510(k) decision of Substantially Equivalent on December 22, 1987, 33 days after the submission was received.
What is the product code of K874705?
The FDA product code is JEJ – Tubing, Instrumentation, Bronchoscope (Brush Sheath A/O Aspirating), a Class II (moderate risk) device regulated under 21 CFR 874.4680.