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510(k) K955067

CLEARVIEW C. DIFF A by Unipath , Ltd. — Product Code MCB

K955067 is an FDA 510(k) premarket notification submitted by Unipath , Ltd. for the device "CLEARVIEW C. DIFF A". The FDA issued a decision of Substantially Equivalent on Sep 13, 1996. The device falls under product code MCB (Antigen, C. Difficile), a Class I device regulated under 21 CFR 866.2660. Unipath , Ltd. has 72 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Sep 13, 1996
Date Received
Nov 6, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Antigen, C. Difficile
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type
510(k) Exempt

Other clearances by Unipath , Ltd.

  • K061769 — E.P.T. CERTAINTY 1-STEP PREGNANCY TEST (Jul 3, 2006)
  • K060128 — CLEARBLUE EASY DIGITAL PREGNANCY TEST (May 25, 2006)
  • K051638 — INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBC (Dec 6, 2005)
  • K050930 — E.P.T. CERTAINTY PREGNANCY TEST (May 12, 2005)
  • K042280 — FACT PLUS ONE-STEP PREGNANCY TEST KIT (Sep 10, 2004)
  • K041404 — CLEARBLUE EASY EASY READ PREGNANCY TEST (Jun 8, 2004)
  • K040341 — CLEARBLUE EASY EARLIEST RESULTS PREGNANCY TEST (Mar 8, 2004)
  • K040329 — MODIFICATION TO E.P.T. PREGNANCY TEST (Mar 8, 2004)
  • K033658 — E.P.T. PREGNANCY TEST (Jan 16, 2004)
  • K032939 — EPT CERTAINTY PREGNANCY TEST (Oct 20, 2003)

Other clearances for product code MCB

  • K132010 — VIDAS C DIFFICILE GDH (Oct 9, 2013)
  • K112048 — IMMUNOCARD C. DIFFICILE GDH (Dec 16, 2011)
  • K110620 — PREMIER C. DIFFICILE GDH (May 3, 2011)
  • K053572 — C. DIFF QUIK CHEK (Apr 26, 2006)
  • K974881 — TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN A (Mar 20, 1998)
  • K924062 — MERITEC C. DIFFICILE CONTROLS (Oct 19, 1992)
  • K904329 — CLOSTRIDIUM DIFFICILE TOXIN A ENZYME IMMUNOASSAY (Mar 12, 1991)
  • K895915 — MERITEC(TM) - C. DIFFICILE LATEX TEST SYSTEM (Mar 12, 1990)
  • K833447 — CYTOTOXICITY ASSAY FOR CLOSTRIDIUM- (May 21, 1984)

FDA data resources

Source: FDA 510(k) database entry for K955067. Report a data issue: hello@regdatalab.com.