GRAM STAIN KIT— 510(k) K781584

Substantially Equivalent

Bioscientific

FDA 510(k) clearance K781584 for GRAM STAIN KIT, Substantially Equivalent on 1978-10-10. Applicant: Bioscientific. Device class: 1.

Clearance details

Applicant: Bioscientific
Product code: Code HYI
Device class: Class 1
Regulation: 21 CFR 864.1850
Advisory panel: Hematology
Date received: 1978-09-18
Decision date: 1978-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HYI

K871286 — GRAM IODINE1987-04-08
K842733 — GRAM IODINE1984-08-10
K821977 — GRAMSTAIN SET1982-07-22
K811722 — PARA-PAK1981-07-15
K791711 — IMPROVED GRAM STAIN REAGENTS1979-10-17

More clearances from Bioscientific

K812447 — AMYLASE REAGENT KIT1981-09-09
K811251 — CITRATE BUFFER1981-05-21
K801265 — WHITE BLOOD CELL COUNT CONTROL LEVELS1980-07-14
K801267 — RED BLOOD CELL COUNT & HEMATOCRIT CNTL1980-07-14
K801268 — HEMOGLOBIN CONTROL LEVELS1980-07-14

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