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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 Feb 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 8 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Feb 13, 1980
Date Received
Jan 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
510(k) Exempt

Other clearances by Endocrine-Metabolic Center

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

Other clearances for product code KHQ

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

FDA data resources

Source: FDA 510(k) database entry for K800188. Report a data issue: hello@regdatalab.com.