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510(k) K840589

TRI-TUBE RIA by Nuclear Medical Laboratories, Inc. — Product Code KHQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 1984
Date Received
February 9, 1984
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 Nuclear Medical Laboratories, Inc.

  • K852438 — NML TSH IRMA (July 12, 1985)
  • K844583 — TSH-STAT (March 5, 1985)
  • K840466 — NML CORTISOL RIA (March 30, 1984)
  • K832892 — MODIFIED CHORIO-SHURE (October 28, 1983)
  • K832002 — NML-5010/5020 MULTI-DETECTOR SYSTEM (August 8, 1983)
  • K823679 — NML 6000 CT (January 7, 1983)
  • K823053 — NML-TETRA-TUBE RIA (November 10, 1982)
  • K822298 — DIAGNOSTIC RADIOIMMUNOASSAY FOR QUANTI (September 2, 1982)
  • K820523 — CHORIO-QUANT (March 15, 1982)
  • K812759 — NML CK-MB RIA (October 19, 1981)

Other clearances for product code KHQ

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  • 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)