RANDOX ASSAYED SPECIFIC PROTEIN CONTROL— 510(k) K972608
Substantially EquivalentRandox Laboratories, Ltd.
FDA 510(k) clearance K972608 for RANDOX ASSAYED SPECIFIC PROTEIN CONTROL, Substantially Equivalent on 1997-08-04. Applicant: Randox Laboratories, Ltd.. Device class: 1.
Clearance details
- Applicant
- Randox Laboratories, Ltd.
- Product code
- Code JJY
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- 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 K972608
K-number listed on FDA's recall record- Z-0903-2023 — Liquid Assayed Specific Protein- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2682 Control Level 1
- Z-0904-2023 — Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2683
- Z-0905-2023 — Liquid Assayed Specific Protein Control Level 3- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2684
- Z-2278-2018 — Randox Liquid Assayed Specific Protein Control - Level 1 (SP Control 1), Cat. no. PS2682
- Z-2279-2018 — Randox Liquid Assayed Specific Protein Control - Level 2 (SP Control 2), Cat. no. PS2683
- Z-2280-2018 — Randox Liquid Assayed Specific Protein Control - Level 3 (SP Control 3), Cat. no. PS2684
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K972608.
Data sourced from openFDA. This site is unofficial and independent of the FDA.