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510(k) K873737

NO SPIN(TM) T3 COATED TUBE RADIOIMMUNOASSAY by Cambridge Medical Technology — Product Code CDP

K873737 is an FDA 510(k) premarket notification submitted by Cambridge Medical Technology for the device "NO SPIN(TM) T3 COATED TUBE RADIOIMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on November 24, 1987. The device falls under product code CDP (Radioimmunoassay, Total Triiodothyronine), a Class II device regulated under 21 CFR 862.1710. Cambridge Medical Technology has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 1987
Date Received
September 15, 1987
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 Cambridge Medical Technology

  • K890837 — RIA-GNOST INSULIN (April 26, 1989)
  • K890836 — RIA-GNOST PROGESTERONE (March 16, 1989)
  • K890697 — RIA-GNOST FERRITIN (March 16, 1989)
  • K870573 — T4 NO SPIN(TM) COATED TUBE RADIOIMMUNOASSAY KIT (April 22, 1987)
  • K862871 — RADIOIMMUNOASSAY OF NO SPIN(TM) CORTISOL (August 19, 1986)
  • K860130 — TESTOSTERONE COATED TUBES RADIOIMMUNOASSAY KIT (February 19, 1986)
  • K855169 — T3 UPTAKE RADIOIMMUNOASSAY KIT (February 6, 1986)
  • K850254 — PARATHYROID HORMONE RADIOIMMUNOASSAY KIT (April 3, 1985)
  • K843635 — MATCHED COMPONENT SET FOR RADIOIMMUNO- (September 28, 1984)
  • K841042 — MATCHED COMPONENT SET RADIOIMMUNOASSAY (April 19, 1984)

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