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510(k) K843635

MATCHED COMPONENT SET FOR RADIOIMMUNO- by Cambridge Medical Technology — Product Code JKC

K843635 is an FDA 510(k) premarket notification submitted by Cambridge Medical Technology for the device "MATCHED COMPONENT SET FOR RADIOIMMUNO-". The FDA issued a decision of Substantially Equivalent on September 28, 1984. The device falls under product code JKC (Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)), a Class I device regulated under 21 CFR 862.1245. Cambridge Medical Technology has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 1984
Date Received
September 17, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)
Device Class
Class I
Regulation Number
862.1245
Review Panel
CH
Submission Type

Other clearances by Cambridge Medical Technology

  • K890837 — RIA-GNOST INSULIN (April 26, 1989)
  • K890697 — RIA-GNOST FERRITIN (March 16, 1989)
  • K890836 — RIA-GNOST PROGESTERONE (March 16, 1989)
  • K873737 — NO SPIN(TM) T3 COATED TUBE RADIOIMMUNOASSAY (November 24, 1987)
  • 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)
  • K841042 — MATCHED COMPONENT SET RADIOIMMUNOASSAY (April 19, 1984)

Other clearances for product code JKC

  • K040181 — ACCESS DHEA-S REAGENT ASSAY (March 24, 2004)
  • K003174 — ELECSYS DHEA-S (January 17, 2001)
  • K973897 — DHEA-S (November 13, 1997)
  • K962895 — DSL DHEA-S-7 (September 10, 1996)
  • K955114 — DSL AACTIVE DHEA EIA KIT (February 23, 1996)
  • K950524 — NICHOLS INSTITUTE DIAGNOSTICS DHEA-S CHEMILUMINESCENCE IMMUNOASSAY (May 15, 1995)
  • K942051 — SR1 DHEA-S ENZYME IMMUNOASSAY (July 13, 1994)
  • K935014 — ACTIVE DEHYDROEPIANDROSTERONE (DHEA)(DSL 9000) (May 9, 1994)
  • K935806 — IMMULITE DHEA-S04 (April 26, 1994)
  • K935469 — SYNELISA DHEA-SULFATE (March 22, 1994)

FDA data resources