DIFCO CHLAMYDIA DIRECT DETECTION SYSTEM— 510(k) K862320

Name: FDA 510(k) clearance K862320
Creator: U.S. Food and Drug Administration
Published: 1986-08-19

Substantially Equivalent

Difco Laboratories, Inc.

FDA 510(k) clearance K862320 for DIFCO CHLAMYDIA DIRECT DETECTION SYSTEM, Substantially Equivalent on 1986-08-19. Applicant: Difco Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Difco Laboratories, Inc.
Product code: Code LJP
Device class: Class 1
Regulation: 21 CFR 866.3120
Advisory panel: Microbiology
Date received: 1986-06-18
Decision date: 1986-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ann Arbor, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LJP

view all

K063675 — DIAGNOSTIC HYBRIDS' D3 DFA CHLAMYDIAE CULTURE CONFIRMATION KIT2007-09-24
K941714 — CHLAMYDIA TRACHOMATIS ANTIGEN TEST1994-07-18
K901243 — CHLAMYDIA-CEL IMMUNOFLUORENSCENCE (IF) TEST1990-05-21
K900870 — PATHODX CHLAMYDIA TRACHOMATIS DIRECT SPECIMEN TEST1990-04-16
K895839 — PATHODX CHLAMYDIA CULTURE CONFIRMATION PKCC11990-02-01

More clearances from Difco Laboratories, Inc.

view all

K971120 — DISPENS-O-DISC (TM) LEVOFLOXACIN1997-04-14
K971211 — DISPENS-O-DISC SPARFLOXACIN1997-04-14
K963508 — DISPENS-O-DISC MEROPENEM1996-09-26
K961148 — CEFEPIME DISPANS-O-DISC (CEFEPLIME - 30MCG)1996-04-26
K954783 — DRYSLIDE CARTARRHALIS1996-02-06

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