OLYMPUS CREATININE REAGENT— 510(k) K934361

Substantially Equivalent

Olympus Corp.

FDA 510(k) clearance K934361 for OLYMPUS CREATININE REAGENT, Substantially Equivalent on 1993-11-16. Applicant: Olympus Corp.. Device class: 2.

Clearance details

Applicant: Olympus Corp.
Product code: Code CGX
Device class: Class 2
Regulation: 21 CFR 862.1225
Advisory panel: Clinical Chemistry
Date received: 1993-09-08
Decision date: 1993-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Success, NY, US

Download summary PDF View on FDA.gov ↗

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More clearances from Olympus Corp.

K915402 — EW-10 AND EW-201995-06-23
K933200 — OLYMPUS PBD STENTS1995-04-05
K942338 — OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIES1994-11-30
K931763 — HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS1994-08-29
K934835 — FLOVAL1994-06-21

Recalls naming K934361

K-number listed on FDA's recall record

Z-0958-2013 — Creatinine, Part Numbers OSR6178, OSR6678 Product Usage: System reagent for the quantitative determination of Creatinine in human serum and urine on Beckman Coulter AU analyzers.Class II·Terminated·Beckman Coulter Inc.·20121228

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K934361.

Data sourced from openFDA. This site is unofficial and independent of the FDA.