CIW — Starch-Dye Bound Polymer, Amylase Class II
FDA product code CIW covers "Starch-Dye Bound Polymer, Amylase", a Class II medical device regulated under 21 CFR 862.1070. Submissions are reviewed by the Clinical Chemistry panel. At least 8 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- CIW
- Device Class
- Class II
- Regulation Number
- 862.1070
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K931559 | data medical associates | DMA AMYLASE PROCEDURE | October 28, 1993 |
| K924339 | olympus | OLYMPUS AMYLASE REAGENT | October 19, 1992 |
| K884382 | em diagnostic systems | AMYLASE TEST (AMYL) ITEM NUMBER: 65653 | January 11, 1989 |
| K850639 | bio-analytics laboratories | ENZYMATIC ALPHA-AMYLASE REAGENT KIT | March 5, 1985 |
| K812027 | eastman kodak | KODAK EKTACHEM CLIN. CHEM. SLIDES (AMYL) | August 3, 1981 |
| K810584 | pharmacia | PHADEBAS ISOAMYLASE TEST | May 13, 1981 |
| K810669 | calbiochem-behring | PANTRAK E.K. | March 31, 1981 |
| K782032 | boehringer mannheim | UNITEST AMYLASE | March 2, 1979 |