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510(k) K830900

UPTAKE T3 RADIOIMMUNOASSAY KIT by Medical & Scientific Designs, Inc. — Product Code KHQ

K830900 is an FDA 510(k) premarket notification submitted by Medical & Scientific Designs, Inc. for the device "UPTAKE T3 RADIOIMMUNOASSAY KIT". The FDA issued a decision of Substantially Equivalent on April 18, 1983. The device falls under product code KHQ (Radioassay, Triiodothyronine Uptake), a Class II device regulated under 21 CFR 862.1715. Medical & Scientific Designs, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 1983
Date Received
March 21, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioassay, Triiodothyronine Uptake
Device Class
Class II
Regulation Number
862.1715
Review Panel
CH
Submission Type

Other clearances by Medical & Scientific Designs, Inc.

  • K862960 — PHASE II FERRITIN RADIOIMMUNOASSAY KIT (August 27, 1986)
  • K853224 — PHASE II B-12/FOLATE KIT (October 3, 1985)
  • K840901 — PHASE II FREE T4 KIT (April 25, 1984)
  • K840328 — PHASE II HCG KIT (April 19, 1984)
  • K834219 — PHASE II CORTISOL KIT (February 4, 1984)
  • K833789 — PHASE II THEOPHYLLINE RADIOIMMUNOASSAY (January 24, 1984)
  • K832499 — PHASE II TSH KIT (September 12, 1983)
  • K832209 — KINETI COUNT 24 GAMMA COUNTER (August 24, 1983)
  • K832210 — GAMMA PHOTON GAMMA COUNTER (August 24, 1983)
  • K831064 — PHASE II T3 RADIOIMMUNOASSAY KIT (May 9, 1983)

Other clearances for product code KHQ

  • K981375 — ACE T UPTAKE REAGENT TU CALIBRATORS (June 10, 1998)
  • K980088 — T-UPTAKE MICROPLATE EIA (February 4, 1998)
  • K970539 — CHIRON DIAGNOSTICS ACS:180TU P (March 24, 1997)
  • K964308 — VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAK (November 27, 1996)
  • K961488 — ELECSYS T-UPTAKE ASSAY (June 12, 1996)
  • K954807 — CEDIA T UPTAKE ASSAY (December 21, 1995)
  • K951586 — T-UPTAKE EIA TEST (May 15, 1995)
  • K933414 — STRATUS(R) THYROID UPTAKE FLUOR ENZYME IMMUNOASSAY (November 22, 1994)
  • K934312 — AXSYM(TM) T-UPTAKE (June 21, 1994)
  • K935816 — VIDAS T UPTAKE (March 22, 1994)

FDA data resources