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510(k) K914801

IMMUNOWELL DSDNA ANTIBODY TEST by General Biometrics, Inc. — Product Code DHC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 1991
Date Received
October 24, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Systemic Lupus Erythematosus
Device Class
Class II
Regulation Number
866.5820
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)
  • 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)

Other clearances for product code DHC

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  • K001398 — REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT (March 30, 2001)
  • K930421 — ELIAS DSDNA ABS (March 10, 1993)
  • K930247 — HUMAN A-DS DNA EIA KIT FOR DIAGNOSTIC USE (March 10, 1993)
  • K885048 — ACCESS R-CLONE ANA PROFILE ASSAY (January 24, 1989)
  • K872910 — IMMUNO/SLE (August 12, 1987)
  • K821385 — SERO/TEX LE TEST (May 28, 1982)
  • K810981 — ANTI NDNA IMMUNOFLOURESCENT TEST SYS (April 29, 1981)
  • K810226 — SLE ANTI-N-DNA LATEX TEST (February 9, 1981)
  • K800992 — CORDIA NP (May 8, 1980)