GC BASE W/ 1% GCHI— 510(k) K954986

Substantially Equivalent

Remel, L.P.

FDA 510(k) clearance K954986 for GC BASE W/ 1% GCHI, Substantially Equivalent on 1996-02-16. Applicant: Remel, L.P.. Device class: 2.

Clearance details

Applicant: Remel, L.P.
Product code: Code JTY
Device class: Class 2
Regulation: 21 CFR 866.2410
Advisory panel: Microbiology
Date received: 1995-10-31
Decision date: 1996-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lenexa, KS, US

Download summary PDF View on FDA.gov ↗

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More clearances from Remel, L.P.

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K964421 — REMEL MEROPENEM 10UG SUSCEPTIBILITY DISK1996-12-06
K961046 — 10B ARGININE BROTH1996-09-18
K955143 — RPR LIQUID CONTROLS1996-07-30

Recalls naming K954986

K-number listed on FDA's recall record

Z-2623-2026 — GC Agar Base (150mm) 10/PK R04030; GC Agar Base (100mm) 10/PK R01460Class II·Ongoing·Remel, Inc·20260603

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K954986.

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