ANTI-CHLAMYDIA TRACHOMATIS KIT— 510(k) K842658

Substantially Equivalent

Amico Lab, Inc.

FDA 510(k) clearance K842658 for ANTI-CHLAMYDIA TRACHOMATIS KIT, Substantially Equivalent on 1984-10-01. Applicant: Amico Lab, Inc.. Device class: 1.

Clearance details

Applicant: Amico Lab, Inc.
Product code: Code LJP
Device class: Class 1
Regulation: 21 CFR 866.3120
Advisory panel: Microbiology
Date received: 1984-07-10
Decision date: 1984-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LJP

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 Amico Lab, Inc.

K842662 — ANTI-EPSTEIN-BARR VIRUS KIT1985-12-12
K842529 — AMIZYME-CMV KIT1985-12-06
K842530 — AMIZYME-EBV TEST KIT1985-12-06
K842531 — AMIZYME-HSV TYPES 1 & 2 TEST KITS1985-12-06
K842661 — ANTI-CYTOMEGALOVIRUS KIT1985-12-06

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