Home / 510(k) Clearances / K940557

510(k) K940557

STAPHYTECT-OD by Unipath , Ltd. — Product Code LHJ

K940557 is an FDA 510(k) premarket notification submitted by Unipath , Ltd. for the device "STAPHYTECT-OD". The FDA issued a decision of Substantially Equivalent on July 28, 1994. The device falls under product code LHJ (Staphylococcus Aureus Protein A Insoluble), a Class I device regulated under 21 CFR 866.3700. Unipath , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1994
Date Received
February 7, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Staphylococcus Aureus Protein A Insoluble
Device Class
Class I
Regulation Number
866.3700
Review Panel
MI
Submission Type

Other clearances by Unipath , Ltd.

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

Other clearances for product code LHJ

  • K842709 — IMMUSTAPH LATEX AGGLUTINATION KIT (August 3, 1984)
  • K812181 — STAPHYLOCOCCAL PROTEIN A INSOLUBLE (August 25, 1981)

FDA data resources