GELRITE— 510(k) K820610

Substantially Equivalent

Kelco

FDA 510(k) clearance K820610 for GELRITE, Substantially Equivalent on 1982-10-27. Applicant: Kelco. Device class: 1.

Clearance details

Applicant: Kelco
Product code: Code JSK
Device class: Class 1
Regulation: 21 CFR 866.2450
Advisory panel: Microbiology
Date received: 1982-03-08
Decision date: 1982-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JSK

K881949 — ATS NAC-PAC SET1988-05-25
K881879 — ATS M/15 PHOSPHATE BUFFER, PRODUCT #034-421988-05-13
K881566 — HEMOGLOBIN POWDER1988-04-18
K861997 — PENICILLIN-STREPTOMYCIN-FUNGIZONE MIXTURE1986-06-10
K861791 — PENICILLIN-STREPTOMYCIN-FUNGIZONE1986-05-20

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