Pantrak E.K.
FDA 510(k) K810669 · Calbiochem-Behring Corp.
510(k) numberK810669
Submission
- Device name
- Pantrak E.K.
- Applicant
- Calbiochem-Behring Corp.
Walker, MI, US - Received
- March 12, 1981
- Decision date
- March 31, 1981
- 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 |
| K782032 | Unitest AmylaseCIW · Traditional | Boehringer Mannheim Corp. | 03/02/1979SE |
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| K830214 | Aft System IIIDHN · Traditional | 03/09/1983SE |
| K820812 | Creatine Kinase-Mb KitJHY · Traditional | 04/12/1982SE |
| K813493 | Enzygnost TM Rubella IgmLFX · Traditional | 03/04/1982SE |
| K820088 | Aft System Proficiency Testing ProgramDBL · Traditional | 01/26/1982SE |
| K812458 | PadacJTO · Traditional | 09/23/1981SE |
| K810718 | C-Peptice ReagentsJKD · Traditional | 03/31/1981SE |
| K810404 | Rheumatoid Factors Reference SerumDHR · Traditional | 03/11/1981SE |
| K810309 | Rubella Antibodies Test ReagentsGOL · Traditional | 03/11/1981SE |
Questions and answers
When was Pantrak E.K. cleared by the FDA?
Pantrak E.K. (K810669) received a 510(k) decision of Substantially Equivalent on March 31, 1981, 19 days after the submission was received.
What is the product code of K810669?
The FDA product code is CIW – Starch-Dye Bound Polymer, Amylase, a Class II (moderate risk) device regulated under 21 CFR 862.1070.