CIJ — Saccharogenic, Amylase Class II
FDA Device Classification
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 |
| K873572 | instrumentation laboratory | IL 35260, IL TEST AMYLASE REAGENT | October 20, 1987 |
| K873250 | roche diagnostic systems | ISOMUNE-AMYLASE AND ISOMUNE-AMYLASE CONTROL | 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 |