SYNCOR TECH CHLAMYDIA TISSUE CULTURE TEST— 510(k) K844582

Name: FDA 510(k) clearance K844582
Creator: U.S. Food and Drug Administration
Published: 1985-01-16

Substantially Equivalent

Syncor Intl. Corp.

FDA 510(k) clearance K844582 for SYNCOR TECH CHLAMYDIA TISSUE CULTURE TEST, Substantially Equivalent on 1985-01-16. Applicant: Syncor Intl. Corp.. Device class: 1.

Clearance details

Applicant: Syncor Intl. Corp.
Product code: Code LJP
Device class: Class 1
Regulation: 21 CFR 866.3120
Advisory panel: Microbiology
Date received: 1984-11-23
Decision date: 1985-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sylmar, CA, 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 Syncor Intl. Corp.

view all

K945825 — SECURE SAFETY INSERT1995-04-10
K851828 — IRRADIATOR FOR BIOLOGICAL MATERIALS IBL-437-C1985-09-19
K850433 — CESIUM 137 ENDOMETRIAL SOURCE1985-08-21
K852023 — CESIUM 137 SOURCE, CSM-4, CSM-11, CSM-411985-08-21
K852665 — SYNCOR TRICH DIRECT IMMUNOFLUORESCENCE ASSAY1985-08-13

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