TISSUE CULTURE FLASK— 510(k) K864021

Substantially Equivalent

Fenwal Laboratories

FDA 510(k) clearance K864021 for TISSUE CULTURE FLASK, Substantially Equivalent on 1986-10-29. Applicant: Fenwal Laboratories. Device class: 1.

Clearance details

Applicant: Fenwal Laboratories
Product code: Code KJA
Device class: Class 1
Regulation: 21 CFR 864.2240
Advisory panel: Hematology
Date received: 1986-10-15
Decision date: 1986-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Round Lake, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KJA

K972404 — VACUTAINER BRAND SAFETY BLOOD COLLECTION ASSEMBLY(MULTIPLE)1997-07-22
K933228 — KAPTON PEEL POUCH1994-03-30
K885121 — CELL SCRAPER1988-12-28
K873889 — TISSUE CULTURE TUBES1987-11-25
K873890 — TISSUE CULTURE FLASKS1987-11-25

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