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510(k) K800188

EMC-M-180, T3 UPTAKE - 100 TUBES by Endocrine-Metabolic Center — Product Code KHQ

K800188 is an FDA 510(k) premarket notification submitted by Endocrine-Metabolic Center for the device "EMC-M-180, T3 UPTAKE - 100 TUBES". The FDA issued a decision of Substantially Equivalent on February 13, 1980. The device falls under product code KHQ (Radioassay, Triiodothyronine Uptake), a Class II device regulated under 21 CFR 862.1715. Endocrine-Metabolic Center has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 1980
Date Received
January 29, 1980
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 Endocrine-Metabolic Center

  • K821131 — RADIOIMMUNOASSAY PARATHYROID HORMONE MID (June 2, 1982)
  • K811993 — RADIOIMMUNOASSAY, FOLLICLE STIMULATING (August 3, 1981)
  • K811994 — RADIOIMMUNOASSAY LUTEINIZING HORMONE (July 27, 1981)
  • K810948 — RADIOIMMUNOASSAY THYROID STIM. HORM. KIT (April 17, 1981)
  • K810351 — RADIOIMMUNOASSAY, TOTAL TRIIODOTHRONIE (February 23, 1981)
  • K800187 — EMC-M-175, THYROXINE - 100 TUBES (February 13, 1980)
  • K790602 — RIA, DIGNXIN-125-I (July 30, 1979)
  • K790630 — RIA, INSULIN, DOUBLE ANTIBODY (July 24, 1979)

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