Unitest Amylase
FDA 510(k) K782032 · Boehringer Mannheim Corp.
510(k) numberK782032
Submission
- Device name
- Unitest Amylase
- Applicant
- Boehringer Mannheim Corp.
Mchenry, IL, US - Received
- December 6, 1978
- Decision date
- March 2, 1979
- 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 |
| 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 |
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| 510(k) | Device | Decision |
|---|---|---|
| K984326 | Elecys Ige AssayJHR · Traditional | 02/08/1999SE |
| K983047 | Accu-Chek HQ SystemLFR · Traditional | 02/05/1999SE |
| K984419 | Elecsys Ige CalcheckJJY · Traditional | 02/02/1999SE |
| K984425 | Modification of Preciset Serum Proteins CalibratorJIX · Traditional | 01/20/1999SE |
| K984372 | Elecsys Calcheck Troponin TJJY · Traditional | 12/14/1998SE |
| K984105 | Elecsys Troponin T Stat TestMMI · Traditional | 12/08/1998SE |
| K983503 | Roche Diagnostics, Boehringer Mannheim Corporation Inorganic Phosphorus Reagent Catalog…CEO · Traditional | 12/01/1998SE |
| K983469 | Preciset Serum Proteins CalibratorJIX · Traditional | 11/25/1998SE |
| K983185 | Boehringer Mannheim Tina-Quant Ige TestDGC · Traditional | 11/12/1998SE |
| K983510 | Chemstrip 101 Urine AnalyzerKQO · Special | 10/27/1998SE |
Questions and answers
When was Unitest Amylase cleared by the FDA?
Unitest Amylase (K782032) received a 510(k) decision of Substantially Equivalent on March 2, 1979, 86 days after the submission was received.
What is the product code of K782032?
The FDA product code is CIW – Starch-Dye Bound Polymer, Amylase, a Class II (moderate risk) device regulated under 21 CFR 862.1070.