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 Jul 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 72 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jul 28, 1994
Date Received
Feb 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
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 LHJ

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

FDA data resources

Source: FDA 510(k) database entry for K940557. Report a data issue: hello@regdatalab.com.