Olympus Amylase Reagent
FDA 510(k) K924339 · Olympus Corp.
510(k) numberK924339
Submission
- Device name
- Olympus Amylase Reagent
- Applicant
- Olympus Corp.
Lake Success, NY, US - Received
- August 28, 1992
- Decision date
- October 19, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| K884382 | Amylase Test (Amyl) Item Number: 65653CIW · Traditional | Em Diagnostic Systems, Inc. | 01/11/1989SE |
| 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 |
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Questions and answers
When was Olympus Amylase Reagent cleared by the FDA?
Olympus Amylase Reagent (K924339) received a 510(k) decision of Substantially Equivalent on October 19, 1992, 52 days after the submission was received.
What is the product code of K924339?
The FDA product code is CIW – Starch-Dye Bound Polymer, Amylase, a Class II (moderate risk) device regulated under 21 CFR 862.1070.