Home / 510(k) Clearances / K821385

510(k) K821385

SERO/TEX LE TEST by Texas Immunology, Inc. — Product Code DHC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 1982
Date Received
May 10, 1982
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 Texas Immunology, Inc.

  • K991465 — DRUG STOP (December 10, 1999)
  • K980153 — DRUG CHECK (March 27, 1998)
  • K973208 — FIRST SIGN (October 20, 1997)
  • K972094 — TARGET CARDIAC TROPONIN I TEST (July 23, 1997)
  • K963680 — TARGET MYOGLOBIN TEST (February 6, 1997)
  • K912246 — TARGET MICROALBUMINURIA TEST (July 19, 1991)
  • K910073 — TARGET ASO TEST (May 21, 1991)
  • K904105 — V-TREND TARGET RF TEST (October 15, 1990)
  • K892231 — V-TREND TARGET CRP TEST (April 21, 1989)
  • K890423 — V-TREND TARGET CRP TEST (February 17, 1989)

Other clearances for product code DHC

  • K001352 — REAADS IGG ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT (April 9, 2001)
  • K001398 — REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT (March 30, 2001)
  • K930247 — HUMAN A-DS DNA EIA KIT FOR DIAGNOSTIC USE (March 10, 1993)
  • K930421 — ELIAS DSDNA ABS (March 10, 1993)
  • K914801 — IMMUNOWELL DSDNA ANTIBODY TEST (December 9, 1991)
  • K885048 — ACCESS R-CLONE ANA PROFILE ASSAY (January 24, 1989)
  • K872910 — IMMUNO/SLE (August 12, 1987)
  • 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)