GRAM IODINE— 510(k) K871286

Substantially Equivalent

Remel Co.

FDA 510(k) clearance K871286 for GRAM IODINE, Substantially Equivalent on 1987-04-08. Applicant: Remel Co.. Device class: 1.

Clearance details

Applicant: Remel Co.
Product code: Code HYI
Device class: Class 1
Regulation: 21 CFR 864.1850
Advisory panel: Hematology
Date received: 1987-03-31
Decision date: 1987-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lenexa, KS, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HYI

K842733 — GRAM IODINE1984-08-10
K821977 — GRAMSTAIN SET1982-07-22
K811722 — PARA-PAK1981-07-15
K791711 — IMPROVED GRAM STAIN REAGENTS1979-10-17
K781584 — GRAM STAIN KIT1978-10-10

More clearances from Remel Co.

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