PRIMA SYSTEM - OLD, BARTELS ELISA - NEW— 510(k) K990664

Name: FDA 510(k) clearance K990664
Creator: U.S. Food and Drug Administration
Published: 1999-03-31

Substantially Equivalent

Intracel Corp.

FDA 510(k) clearance K990664 for PRIMA SYSTEM - OLD, BARTELS ELISA - NEW, Substantially Equivalent on 1999-03-31. Applicant: Intracel Corp.. Device class: 1.

Clearance details

Applicant: Intracel Corp.
Product code: Code LLH
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1999-03-01
Decision date: 1999-03-31
Decision: Substantially Equivalent
Clearance type: Special
Location: Rockville, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLH

view all

K193490 — SensiTox C. difficile Toxin Test2021-07-08
K102242 — OSOM C. DIFFICILE TOXIN A/B TEST2010-12-21
K091109 — XPERT C. DIFFICILE2009-07-09
K090239 — PROGASTRO CD ASSAY2009-04-16
K082499 — C. DIFF QUIK CHEK COMPLETE2009-03-26

More clearances from Intracel Corp.

view all

K003204 — BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KIT2000-11-07
K991074 — BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST1999-12-21
K982311 — BARTELS CINAKIT CMV ANTIGENEMIA1998-12-14
K933878 — ZYMMUNE(TM) CD4/CD8 CELL MONITORING KIT1995-11-14

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