LACTATE DEHYDROGENASE (LD)— 510(k) K970684
Substantially EquivalentRandox Laboratories, Ltd.
FDA 510(k) clearance K970684 for LACTATE DEHYDROGENASE (LD), Substantially Equivalent on 1997-05-07. Applicant: Randox Laboratories, Ltd.. Device class: 2.
Clearance details
- Applicant
- Randox Laboratories, Ltd.
- Product code
- Code CFJ
- Device class
- Class 2
- Regulation
- 21 CFR 862.1440
- 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 K970684
K-number listed on FDA's recall record- Z-2962-2020 — Lactate Dehydrogenase L-P, (LDH) (NAO), Catalog Number LD3842 - Product Usage: device intended for the quantitative in vitro determination of Lactate Dehydrogenase (LD) activity in serum and plasma. This product is suitable for use on the RX series instruments which includes the RX daytona and RX imola.
- Z-2963-2020 — Lactate Dehydrognease P-L, (UV), Catalog Number LD3818 - Product Usage: device intended for the quantitative in vitro determination of Lactate Dehydrogenase (LD) activity in serum and plasma. This product is suitable for use on the RX series instruments which includes the RX daytona and RX imola.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K970684.
Data sourced from openFDA. This site is unofficial and independent of the FDA.