FDA 510(k) Applications for Medical Device Product Code "CIJ"
(Saccharogenic, Amylase)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K980013 | AC BIOCHEMICALS, INC. | AMYLASE | 02/04/1998 |
| K991817 | BAYER CORP. | ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM | 07/22/1999 |
| K023396 | POINTE SCIENTIFIC, INC. | AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS) | 12/23/2002 |
| K953211 | RANDOX LABORATORIES, LTD. | AMYLASE (ETHYLIDENE PNGPG7) KIT | 06/21/1996 |
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