Amylase Test (Amyl) Item Number: 65653
FDA 510(k) K884382 · Em Diagnostic Systems, Inc.
510(k) numberK884382
Submission
- Device name
- Amylase Test (Amyl) Item Number: 65653
- Applicant
- Em Diagnostic Systems, Inc.
Gibbstown, NJ, US - Received
- October 18, 1988
- Decision date
- January 11, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CIW – Starch-Dye Bound Polymer, Amylase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1070
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CIW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K931559 | Dma Amylase ProcedureCIW · Traditional | Data Medical Associates, Inc. | 10/28/1993SE |
| K924339 | Olympus Amylase ReagentCIW · Traditional | Olympus Corp. | 10/19/1992SE |
| K850639 | Enzymatic Alpha-Amylase Reagent KitCIW · Traditional | Bio-Analytics Laboratories, Inc. | 03/05/1985SE |
| K812027 | Kodak Ektachem Clin. Chem. Slides (Amyl)CIW · Traditional | Eastman Kodak Company | 08/03/1981SE |
| K810584 | Phadebas Isoamylase TestCIW · Traditional | Pharmacia, Inc. | 05/13/1981SE |
| K810669 | Pantrak E.K.CIW · Traditional | Calbiochem-Behring Corp. | 03/31/1981SE |
| K782032 | Unitest AmylaseCIW · Traditional | Boehringer Mannheim Corp. | 03/02/1979SE |
More from Boehringer Mannheim Corp.
| 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 Amylase Test (Amyl) Item Number: 65653 cleared by the FDA?
Amylase Test (Amyl) Item Number: 65653 (K884382) received a 510(k) decision of Substantially Equivalent on January 11, 1989, 85 days after the submission was received.
What is the product code of K884382?
The FDA product code is CIW – Starch-Dye Bound Polymer, Amylase, a Class II (moderate risk) device regulated under 21 CFR 862.1070.