Chem-Strate Amylase
FDA 510(k) K792479 · General Diagnostics
510(k) numberK792479
Submission
- Device name
- Chem-Strate Amylase
- Applicant
- General Diagnostics
Mchenry, IL, US - Received
- December 3, 1979
- Decision date
- December 27, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CIJ – Saccharogenic, Amylase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1070
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CIJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K023396 | Amylase EPS-G7 (Liquid) Reagent Set, (Hitachi Analyzers)CIJ · Traditional | Pointe Scientific, Inc., | 12/23/2002SE |
| K991817 | Additional Ims Assays for the Bayer Advia Ims SystemCIJ · Traditional | Bayer Corp. | 07/22/1999SE |
| K980013 | AmylaseCIJ · Traditional | Ac Biochemicals, Inc. | 02/04/1998SE |
| K953211 | Amylase (Ethylidene PNGPG7) KitCIJ · Traditional | Randox Laboratories, Ltd. | 06/21/1996SE |
| K951494 | Amylase Test Item 97381/94 (R1, 97382/94 (R2-SR)CIJ · Traditional | Emd Chemicals, Inc. | 12/11/1995SE |
| K940735 | Liquid Amylase (CNPG3) Reagent SetCIJ · Traditional | Pointe Scientific, Inc., | 08/01/1994SE |
| K940010 | Dma Amylase (Demand) ProcedureCIJ · Traditional | Data Medical Associates, Inc. | 03/11/1994SE |
| K931301 | Olympus Amylase ReagentCIJ · Traditional | Olympus Corp. | 10/18/1993SE |
| K931141 | Biotrol Amylase CNPG3CIJ · Traditional | Biotrol, USA, Inc. | 05/26/1993SE |
| K882225 | -Amylase EpsCIJ · Traditional | Boehringer Mannheim Corp. | 01/03/1989SE |
More from Boehringer Mannheim Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K882663 | Barbiturate Enzyme Immunoassay KitDIS · Traditional | 09/19/1988SE |
| K872882 | Cannabinoid Enzyme Immunoassay KitLDJ · Traditional | 11/03/1987SE |
| K871305 | Cocaine Metabolite Enzyme Immunoassay KitDIO · Traditional | 06/05/1987SE |
| K864993 | Quali. Enzyme Immuno. of Barbiturates in UrineDIS · Traditional | 03/31/1987SE |
| K863877 | Benzodiazepine Enzyme Immunoassay KitJXM · Traditional | 03/12/1987SE |
| K842307 | General Diag. Cefonicid 30MCG AntimicJTN · Traditional | 07/20/1984SE |
| K841465 | General Diagnostics Platelet AntibodyLLG · Traditional | 07/02/1984SE |
| K833709 | Ceftizoxime 30 MCG Antimicrobial DiskJTN · Traditional | 12/30/1983SE |
| K832653 | Cefuroxime 30MCG. Suscep DiskJTN · Traditional | 10/14/1983SE |
| K831179 | Cefazolin 30MCG. Antimicrobial SuscepJTN · Traditional | 05/09/1983SE |
Questions and answers
When was Chem-Strate Amylase cleared by the FDA?
Chem-Strate Amylase (K792479) received a 510(k) decision of Substantially Equivalent on December 27, 1979, 24 days after the submission was received.
What is the product code of K792479?
The FDA product code is CIJ – Saccharogenic, Amylase, a Class II (moderate risk) device regulated under 21 CFR 862.1070.