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510(k) K971658

MOUSE LIVER KIDNEY STOMACH DIAGNOSTIC TEST KIT by Jay H. Geller — Product Code DBL

K971658 is an FDA 510(k) premarket notification submitted by Jay H. Geller for the device "MOUSE LIVER KIDNEY STOMACH DIAGNOSTIC TEST KIT". The FDA issued a decision of Substantially Equivalent on May 23, 1997. The device falls under product code DBL (Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control), a Class II device regulated under 21 CFR 866.5660. Jay H. Geller has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 1997
Date Received
April 14, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
Device Class
Class II
Regulation Number
866.5660
Review Panel
IM
Submission Type

Other clearances by Jay H. Geller

  • K942326 — HUMAN C5 RID KITS (August 24, 1995)
  • K950015 — HUMAN PROTEIN C RID TEST KIT (March 6, 1995)
  • K943334 — HAWLEY RETAINER ORTHODONTIC APPLICANCE KIT (October 5, 1994)

Other clearances for product code DBL

  • K180202 — Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immun (October 19, 2018)
  • K980312 — NOVA LITE ENDOMYSIAL (April 2, 1998)
  • K974169 — WIELISA ANTI-GBM TEST SYSTEM (February 17, 1998)
  • K971464 — IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT (October 29, 1997)
  • K963525 — DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KIT (November 7, 1996)
  • K955431 — RIT LIVER, KIDNEY, STOMACH IFA KIT (April 23, 1996)
  • K953495 — EIA KIT FOR THE DETECTION OF GBM ANTIBODIES (April 10, 1996)
  • K944192 — ANTI-NUCLEAR ANTIBODY (ANA) TEST KIT W/RAT LIVER (March 6, 1995)
  • K944191 — ANTI-NUCLEAR ANTIBODY(ANA) TEST KIT W/MOUSE LIVER (March 6, 1995)
  • K913360 — ANTI-RETICULIN ANTIBODY (ARA) TEST (September 26, 1994)

FDA data resources