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510(k) K971270

DSL ACTIVE T3 EIA by Diagnostic Systems Laboratories, Inc. — Product Code CDP

K971270 is an FDA 510(k) premarket notification submitted by Diagnostic Systems Laboratories, Inc. for the device "DSL ACTIVE T3 EIA". The FDA issued a decision of Substantially Equivalent on May 22, 1997. The device falls under product code CDP (Radioimmunoassay, Total Triiodothyronine), a Class II device regulated under 21 CFR 862.1710. Diagnostic Systems Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 1997
Date Received
April 4, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Total Triiodothyronine
Device Class
Class II
Regulation Number
862.1710
Review Panel
CH
Submission Type

Other clearances by Diagnostic Systems Laboratories, Inc.

  • K061758 — ACTIVE RENIN IRMA (July 28, 2006)
  • K020945 — AXSYM INTACT PTH, MODEL 2G06 (May 31, 2002)
  • K020128 — ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500 (March 1, 2002)
  • K002128 — ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100 (December 5, 2000)
  • K001086 — FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900 (May 18, 2000)
  • K990138 — DSL ACTIVE AFP ELISA, MODEL DSL-10-8400 (June 21, 1999)
  • K981871 — C-REACTIVE PROTEIN ELISA, MODEL NUMBER DSL-10-42100 (November 9, 1998)
  • K973243 — ACTIVE PSA ELISA (DSL-10-9700) (August 3, 1998)
  • K973244 — ACTIVE PSA IRMA (DSL-9700) (August 3, 1998)
  • K981607 — ACTIVE RENIN IRMA MODEL NUMBER DSL-25100 (May 27, 1998)

Other clearances for product code CDP

  • K001607 — REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104) (October 5, 2000)
  • K991692 — CHIRON DIAGNOSTICS ACS: 180 FT3 (June 18, 1999)
  • K991311 — TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005 (June 2, 1999)
  • K991252 — AIA-PACK FT3 ASSAY (May 11, 1999)
  • K981824 — OPTICOAT T3 EIA KIT (December 22, 1998)
  • K983434 — ABBOTT ARCHITECT TOTAL T3 (November 20, 1998)
  • K983439 — ABBOTT ARCHITECT FREE T3 (November 20, 1998)
  • K974027 — AURAFLEX FT3 150 TEST PACK, AURAFLEX FT3 CALIBRATOR PACK (February 2, 1998)
  • K974634 — IMMULITE FREE T3 (January 2, 1998)
  • K973966 — ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (October 31, 1997)

FDA data resources