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510(k) K990664

PRIMA SYSTEM - OLD, BARTELS ELISA - NEW by Intracel Corp. — Product Code LLH

K990664 is an FDA 510(k) premarket notification submitted by Intracel Corp. for the device "PRIMA SYSTEM - OLD, BARTELS ELISA - NEW". The FDA issued a decision of Substantially Equivalent on March 31, 1999. The device falls under product code LLH (Reagents, Clostridium Difficile Toxin), a Class I device regulated under 21 CFR 866.2660. Intracel Corp. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1999
Date Received
March 1, 1999
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reagents, Clostridium Difficile Toxin
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type

Other clearances by Intracel Corp.

  • K003204 — BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KIT (November 7, 2000)
  • K991074 — BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST (December 21, 1999)
  • K982311 — BARTELS CINAKIT CMV ANTIGENEMIA (December 14, 1998)
  • K933878 — ZYMMUNE(TM) CD4/CD8 CELL MONITORING KIT (November 14, 1995)

Other clearances for product code LLH

  • K193490 — SensiTox C. difficile Toxin Test (July 8, 2021)
  • K102242 — OSOM C. DIFFICILE TOXIN A/B TEST (December 21, 2010)
  • K091109 — XPERT C. DIFFICILE (July 9, 2009)
  • K090239 — PROGASTRO CD ASSAY (April 16, 2009)
  • K082499 — C. DIFF QUIK CHEK COMPLETE (March 26, 2009)
  • K081920 — BD GENEOHM CDIFF ASSAY (December 19, 2008)
  • K080931 — VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAY (June 11, 2008)
  • K072138 — VIDAS C. DIFFICILE TOXIN A&B (CDAB) ASSAY, MODEL: 30 118 (December 21, 2007)
  • K050891 — TOX A/B QUICK CHEK (July 25, 2005)
  • K041951 — XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B (November 15, 2004)

FDA data resources