X-FACTOR DISCS— 510(k) K802500

Substantially Equivalent

Oxoid U.S.A., Inc.

FDA 510(k) clearance K802500 for X-FACTOR DISCS, Substantially Equivalent on 1980-11-12. Applicant: Oxoid U.S.A., Inc.. Device class: 1.

Clearance details

Applicant: Oxoid U.S.A., Inc.
Product code: Code JTO
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1980-10-10
Decision date: 1980-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JTO

K050352 — IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT2005-09-01
K970832 — PYR SWAB1997-04-24
K970834 — GRAM SWAB1997-04-17
K970833 — INDOLE SWAB1997-04-02
K970009 — LYFO(TM) DIFFERENTIAL DISK-BACITRACIN1997-02-06

More clearances from Oxoid U.S.A., Inc.

K891593 — LISTERIA SELECTIVE ENRICHMENT MEDIUM1989-06-09
K884026 — ESCHERICHIA COLI 0157 LATEX AGGLUTINATION TEST KIT1989-02-03
K884208 — LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION)1988-10-25
K874303 — STAPHYLASE TEST1987-11-06
K872956 — SORBITOL MACCONKEY AGAR NO. 3 CM 8131987-08-10

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