ISOTONIC BUFFERED SALINE— 510(k) K780830

Substantially Equivalent

Harleco

FDA 510(k) clearance K780830 for ISOTONIC BUFFERED SALINE, Substantially Equivalent on 1978-06-14. Applicant: Harleco. Device class: 1.

Clearance details

Applicant: Harleco
Product code: Code GIF
Device class: Class 1
Regulation: 21 CFR 864.8200
Advisory panel: Hematology
Date received: 1978-05-19
Decision date: 1978-06-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GIF

K883989 — KVM ISOTONIC FLUSH SOLUTION1988-10-12
K883990 — KVM ISOTONIC DILUENT1988-10-12
K882490 — HYCEL QUICK-LYSING HEMOGLOBIN REAGENT1988-07-25
K882267 — SYSMEX QUICKLYSER-II (QLS-200A)1988-07-12
K881130 — CELL-DYN ISOTONIC DILUENT1988-03-31

More clearances from Harleco

K820233 — ULTRAZYME PLUS GAMMA GT(65055-65056)1982-02-12
K813427 — ULTRACHEM GLUC-DH1981-12-31
K813038 — ULTRACHEM TP, ITEM #649741981-11-10
K813039 — ULTRACHEM E-CHOL, ITEM #650251981-11-10
K813040 — ULTRACHEM CA, ITEM #649751981-11-10

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