Home / 510(k) Clearances / K870573

510(k) K870573

T4 NO SPIN(TM) COATED TUBE RADIOIMMUNOASSAY KIT by Cambridge Medical Technology — Product Code CDX

K870573 is an FDA 510(k) premarket notification submitted by Cambridge Medical Technology for the device "T4 NO SPIN(TM) COATED TUBE RADIOIMMUNOASSAY KIT". The FDA issued a decision of Substantially Equivalent on April 22, 1987. The device falls under product code CDX (Radioimmunoassay, Total Thyroxine), a Class II device regulated under 21 CFR 862.1700. Cambridge Medical Technology has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 1987
Date Received
February 10, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Total Thyroxine
Device Class
Class II
Regulation Number
862.1700
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)
  • K873737 — NO SPIN(TM) T3 COATED TUBE RADIOIMMUNOASSAY (November 24, 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 CDX

  • K961490 — ELECSYS T4 ASSAY (June 13, 1996)
  • K954312 — ACTIVE THYROXINE RIA (October 7, 1995)
  • K943416 — DELFIA NEONATAL THYROXINE KIT (March 10, 1995)
  • K934384 — AXSYM(TM) TOTAL T4 (June 21, 1994)
  • K932980 — TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116 (October 18, 1993)
  • K933426 — STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO (August 26, 1993)
  • K931295 — IQ TT4 ASSAY (July 20, 1993)
  • K926563 — AUTOBEAD(TM) T4 ENZYME IMMUNOASSAY TEST KIT (March 18, 1993)
  • K925110 — ABBOTT IMX T4 (January 26, 1993)
  • K925109 — ABBOTT TDX/TDXFLX TT4 (January 4, 1993)

FDA data resources