LAB-TEK JEMBEC G.C. CULTURE SYSTEM— 510(k) K811382

Name: FDA 510(k) clearance K811382
Creator: U.S. Food and Drug Administration
Published: 1981-06-16

Substantially Equivalent

Miles Laboratories, Inc.

FDA 510(k) clearance K811382 for LAB-TEK JEMBEC G.C. CULTURE SYSTEM, Substantially Equivalent on 1981-06-16. Applicant: Miles Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Miles Laboratories, Inc.
Product code: Code JTY
Device class: Class 2
Regulation: 21 CFR 866.2410
Advisory panel: Microbiology
Date received: 1981-05-15
Decision date: 1981-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JTY

view all

K210511 — InTray GC2021-10-20
K993033 — INTRAY GC1999-12-16
K954986 — GC BASE W/ 1% GCHI1996-02-16
K950196 — CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA1995-06-30
K933122 — MICROBIOLOGICAL CULTURE MEDIA,MARTIN LEWIS AGAR1994-02-09

More clearances from Miles Laboratories, Inc.

view all

K880605 — LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTER1988-05-26
K874909 — MICRO-BUMINTEST REAGENT TABLETS1988-04-28
K875079 — MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULE1988-04-05
K871835 — GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINT1987-12-22
K872120 — SERALYZER III BLOOD CHEMISTRY ANALYZER1987-10-28

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