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510(k) K902938

IMMUNODOT AUTOIMMUNITY SCREENING PANEL 3 by General Biometrics, Inc. — Product Code LLL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 1990
Date Received
July 3, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Extractable Antinuclear Antibody, Antigen And Control
Device Class
Class II
Regulation Number
866.5100
Review Panel
IM
Submission Type

Other clearances by General Biometrics, Inc.

  • K924843 — IMMUNODOT(R) ENA/DNA AUTOIMMUNITY SCREENING PANEL (December 1, 1992)
  • K920400 — IMMUNOWELL CARDIOLIPIN ANTIBODY (IGG) TEST (August 20, 1992)
  • K920401 — IMMUNOWELL CARDIOLIPIN ANTIBODY (IGM) TEST (August 20, 1992)
  • K911627 — IMMUNODOT BORRELIA (LYME) TEST (April 8, 1992)
  • K911599 — IMMUNOWELL LYME (P39 RECOMBINANT) TEST (December 30, 1991)
  • K911590 — IMMUNOWELL BORRELIA (LYME)TEST (December 20, 1991)
  • K914801 — IMMUNOWELL DSDNA ANTIBODY TEST (December 9, 1991)
  • K911849 — IMMUNOWELL SJOGRENS SYNDROME A (RO)ANTIBODY TEST (May 7, 1991)
  • K911851 — IMMUNOWELL SM ANTIBODY TEST (May 7, 1991)
  • K911848 — IMMUNOWELL RNP/SM ANTIBODY TEST (May 7, 1991)

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