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510(k) K924843

IMMUNODOT(R) ENA/DNA AUTOIMMUNITY SCREENING PANEL by General Biometrics, Inc. — Product Code LLL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 1, 1992
Date Received
September 28, 1992
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.

  • K920401 — IMMUNOWELL CARDIOLIPIN ANTIBODY (IGM) TEST (August 20, 1992)
  • K920400 — IMMUNOWELL CARDIOLIPIN ANTIBODY (IGG) 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)
  • K911850 — IMMUNWELL SJOGREN`S SYNDROME B (LA) ANTIBODY TEST (May 7, 1991)

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