Synchron Systems Pancreatic Amylase (Pam) Reagent
FDA 510(k) K013978 · Beckman Coulter, Inc.
510(k) numberK013978
Submission
- Device name
- Synchron Systems Pancreatic Amylase (Pam) Reagent
- Applicant
- Beckman Coulter, Inc.
Brea, CA, US - Received
- December 3, 2001
- Decision date
- January 15, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JFJ – Catalytic Methods, Amylase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1070
- Specialty
- Clinical Chemistry
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| K080823 | Easyra Amylase, Bun, Glu-H, Trig, Uric ReagentJFJ · Traditional | Medica Corp. | 11/17/2008SE |
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Questions and answers
When was Synchron Systems Pancreatic Amylase (Pam) Reagent cleared by the FDA?
Synchron Systems Pancreatic Amylase (Pam) Reagent (K013978) received a 510(k) decision of Substantially Equivalent on January 15, 2002, 43 days after the submission was received.
What is the product code of K013978?
The FDA product code is JFJ – Catalytic Methods, Amylase, a Class II (moderate risk) device regulated under 21 CFR 862.1070.