URINE DUO— 510(k) K851225

Substantially Equivalent

Culture Kits, Inc.

FDA 510(k) clearance K851225 for URINE DUO, Substantially Equivalent on 1985-08-13. Applicant: Culture Kits, Inc.. Device class: 2.

Clearance details

Applicant: Culture Kits, Inc.
Product code: Code JTZ
Device class: Class 2
Regulation: 21 CFR 866.1700
Advisory panel: Microbiology
Date received: 1985-03-26
Decision date: 1985-08-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwich, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JTZ

K132491 — MUELLER HINTON AGAR2014-06-30
K963036 — MUELLER HINTON II BROTH (CATION-ADJUSTED) WITH LYSED HORSE BLOOD1996-10-07
K960420 — MUELLER HINTON AGAR WITH 5% SHEEP BLOOD1996-04-04
K960313 — MUELLER HINTON AGAR WITH 2% NACI1996-03-25
K945911 — CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGARS1995-04-04

More clearances from Culture Kits, Inc.

K911846 — URI-THREE(TM), MODIFICATION1991-10-04
K854672 — CANDI-KIT TM1986-07-11
K853488 — STAPH KIT1985-08-28
K852582 — GONI-KIT1985-07-12
K852480 — DERM-KIT1985-07-09

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