Pancreatic Amylase, Ethylidene BLOCKED-PNPG7 Enzyme Colorimetric Test
FDA 510(k) K971825 · Randox Laboratories, Ltd.
510(k) numberK971825
Submission
- Device name
- Pancreatic Amylase, Ethylidene BLOCKED-PNPG7 Enzyme Colorimetric Test
- Applicant
- Randox Laboratories, Ltd.
Crumlin, IE - Received
- May 16, 1997
- Decision date
- July 24, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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Questions and answers
When was Pancreatic Amylase, Ethylidene BLOCKED-PNPG7 Enzyme Colorimetric Test cleared by the FDA?
Pancreatic Amylase, Ethylidene BLOCKED-PNPG7 Enzyme Colorimetric Test (K971825) received a 510(k) decision of Substantially Equivalent on July 24, 1997, 69 days after the submission was received.
What is the product code of K971825?
The FDA product code is JFJ – Catalytic Methods, Amylase, a Class II (moderate risk) device regulated under 21 CFR 862.1070.