Cobas Reagent for A-Amylase
FDA 510(k) K801295 · Roche Analytical Instruments, Inc.
510(k) numberK801295
Submission
- Device name
- Cobas Reagent for A-Amylase
- Applicant
- Roche Analytical Instruments, Inc.
Mchenry, IL, US - Received
- June 2, 1980
- Decision date
- July 8, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JFJ – Catalytic Methods, Amylase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1070
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JFJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K210633 | Amylase2JFJ · Traditional | Abbott Ireland Diagnostics Division | 05/26/2022SE |
| K191454 | Atellica CH Amylase_2 (AMY_2)JFJ · Traditional | Siemens Healthcare Diagnostics, Inc. | 07/30/2019SE |
| K182474 | alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT…JFJ · Traditional | Biosystems S.A. | 05/02/2019SE |
| K130685 | Hitachi Clinical Analyzer S Test Reagent Cartridges for LD and AmyJFJ · Traditional | Hitachi Chemical Diagnostics, Inc. | 08/09/2013SE |
| K122858 | Eltech Chinical System Amylase SL Elitech Clinical Systems ELICAL2 Eltech Clinical…JFJ · Traditional | Elitechgroup | 10/03/2012SE |
| K091846 | Synchron Systems G7 Amylase (AMY7) Reagent with Model(S) A71607JFJ · Traditional | Beckman Coulter, Inc. | 10/16/2009SE |
| K080823 | Easyra Amylase, Bun, Glu-H, Trig, Uric ReagentJFJ · Traditional | Medica Corp. | 11/17/2008SE |
| K070064 | Amylase Eps ReagentJFJ · Traditional | Thermo Fisher Scientific | 05/22/2007SE |
| K062180 | Abx Pentra Amylase CP; Multical; N Control; P Control; Clean-Chem CP; Clean-Chem 99 CPJFJ · Traditional | Horiba Abx | 10/02/2006SE |
| K051447 | Sentinel Pancreatic AmylaseJFJ · Traditional | Sentinel Ch. Srl | 01/26/2006SE |
More from Sentinel Ch. Srl
| 510(k) | Device | Decision |
|---|---|---|
| K801299 | Cobas Ck-Nac ReagentCGS · Traditional | 07/14/1980SE |
| K801298 | Cobas Reagent for Triglycerides & CobasCDT · Traditional | 07/08/1980SE |
| K801297 | Cobas Reagent for Glucose RapidCFR · Traditional | 06/30/1980SE |
| K801296 | Cobas Reagent for CholesterolCHH · Traditional | 06/30/1980SE |
| K801243 | Cobas Reagents for Uric AcidCDO · Traditional | 06/26/1980SE |
| K801242 | Cobas Reagent for Alkaline PhosphataseCJE · Traditional | 06/20/1980SE |
| K801118 | Cobas Reagent for Ast (Sgot)CIT · Traditional | 06/20/1980SE |
| K801116 | Cobas Reagent for BunCDQ · Traditional | 06/17/1980SE |
| K801119 | Cobas Reagent for Alt (GPT)CKA · Traditional | 06/09/1980SE |
| K801117 | Cobas Total Bilirubin Reagent & DiluentCIG · Traditional | 06/09/1980SE |
Questions and answers
When was Cobas Reagent for A-Amylase cleared by the FDA?
Cobas Reagent for A-Amylase (K801295) received a 510(k) decision of Substantially Equivalent on July 8, 1980, 36 days after the submission was received.
What is the product code of K801295?
The FDA product code is JFJ – Catalytic Methods, Amylase, a Class II (moderate risk) device regulated under 21 CFR 862.1070.