PANCREATIC AMYLASE, ETHYLIDENE BLOCKED-PNPG7 ENZYME COLORIMETRIC TEST— 510(k) K971825
Substantially EquivalentRandox Laboratories, Ltd.
FDA 510(k) clearance K971825 for PANCREATIC AMYLASE, ETHYLIDENE BLOCKED-PNPG7 ENZYME COLORIMETRIC TEST, Substantially Equivalent on 1997-07-24. Applicant: Randox Laboratories, Ltd.. Device class: 2.
Clearance details
- Applicant
- Randox Laboratories, Ltd.
- Product code
- Code JFJ
- Device class
- Class 2
- Regulation
- 21 CFR 862.1070
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Crumlin, IE
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More clearances from Randox Laboratories, Ltd.
view allRecalls naming K971825
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K971825.
Data sourced from openFDA. This site is unofficial and independent of the FDA.