Home / 510(k) Clearances / K812497

510(k) K812497

IMMULIK STAIN PLATE by Immulok, Inc. — Product Code IEG

K812497 is an FDA 510(k) premarket notification submitted by Immulok, Inc. for the device "IMMULIK STAIN PLATE". The FDA issued a decision of Substantially Equivalent on September 23, 1981. The device falls under product code IEG (Table, Slide Warming), a Class I device regulated under 21 CFR 864.3010. Immulok, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 1981
Date Received
August 31, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Slide Warming
Device Class
Class I
Regulation Number
864.3010
Review Panel
PA
Submission Type

Other clearances by Immulok, Inc.

  • K830971 — HERPES SIMPLEX VIRUS TYPING REAGENTS (June 30, 1983)
  • K830342 — CULUTURE SET CHLAMYDIA ISOLATION AND (May 4, 1983)
  • K830250 — CVT VIRAL TRANSPORTS (February 28, 1983)
  • K823304 — RIASET PROLACTIN RIA KIT (December 22, 1982)
  • K822785 — FLUOROSET IMMUNOFLUORESCENT ANTIBODY (November 29, 1982)
  • K823055 — FLOUROSET IMMUNOFLUORESCENT ANTIBODY (November 5, 1982)
  • K822606 — CYTOMEGALOVIRUS ANTOBODY IGG (November 1, 1982)
  • K822605 — TOXOPLASMA GONDII ANTIBODY IGG (October 27, 1982)
  • K822607 — ANTINUCLEAR ANTOBODY CELL SUBSTRATE (September 17, 1982)
  • K821567 — IMMULOK CULTURESET (June 25, 1982)

FDA data resources