CIJ — Saccharogenic, Amylase Class II
FDA product code CIJ covers "Saccharogenic, Amylase", a Class II medical device regulated under 21 CFR 862.1070. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- CIJ
- 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 |
|---|---|---|---|
| K023396 | pointe scientific, inc | AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS) | December 23, 2002 |
| K991817 | bayer | ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM | July 22, 1999 |
| K980013 | ac biochemicals | AMYLASE | February 4, 1998 |
| K953211 | randox laboratories | AMYLASE (ETHYLIDENE PNGPG7) KIT | June 21, 1996 |
| K951494 | emd chemicals | AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR) | December 11, 1995 |
| K940735 | pointe scientific, inc | LIQUID AMYLASE (CNPG3) REAGENT SET | August 1, 1994 |
| K940010 | data medical associates | DMA AMYLASE (DEMAND) PROCEDURE | March 11, 1994 |
| K931301 | olympus | OLYMPUS AMYLASE REAGENT | October 18, 1993 |
| K931141 | biotrol, usa | BIOTROL AMYLASE CNPG3 | May 26, 1993 |
| K882225 | boehringer mannheim | -AMYLASE EPS | January 3, 1989 |
| K873250 | roche diagnostic systems | ISOMUNE-AMYLASE AND ISOMUNE-AMYLASE CONTROL | October 20, 1987 |
| K873572 | instrumentation laboratory | IL 35260, IL TEST AMYLASE REAGENT | October 20, 1987 |
| K872831 | biotrol, usa | BIOTROL ALPHA AMYLASE | September 4, 1987 |
| K871943 | behring diagnostics | D.A.T. (TM) AMYLASE REAGENT | June 3, 1987 |
| K864356 | trace scientific | AMYLASE REAGENT | January 21, 1987 |
| K863719 | technicon instruments | AMYLASE,CALCIUM,CHLORIDE & TRIGLYCERIDES ON CHEM 1 | November 13, 1986 |
| K862370 | coulter electronics | DART AMYLASE-D.S. REAGENT SYSTEM | August 1, 1986 |
| K861664 | data medical associates | AMYLASE PROCEDURE | July 1, 1986 |
| K860935 | em diagnostic systems | EMDS AMYLASE (AMYL) TEST PACKS, # 67653/95 | May 23, 1986 |
| K853951 | behring diagnostics | ISOTRAK AMYLASE TEST AMYLASE ISOENZYME | January 7, 1986 |