Home / 510(k) Clearances / K896925

510(k) K896925

T UPTAKE ENZYME IMMUNOASSAY CRIMPED TUBE KIT by In Vitro Diagnostics, Inc. — Product Code KHQ

K896925 is an FDA 510(k) premarket notification submitted by In Vitro Diagnostics, Inc. for the device "T UPTAKE ENZYME IMMUNOASSAY CRIMPED TUBE KIT". The FDA issued a decision of Substantially Equivalent on January 18, 1990. The device falls under product code KHQ (Radioassay, Triiodothyronine Uptake), a Class II device regulated under 21 CFR 862.1715. In Vitro Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 1990
Date Received
December 12, 1989
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 In Vitro Diagnostics, Inc.

  • K896867 — THYROID STIMULATING HORMONE-EIA-XT (February 23, 1990)
  • K896866 — LUTEINIZING HORMONE-EIA-XT (February 13, 1990)
  • K896863 — DIGOXIN-EIA-XT (February 13, 1990)
  • K896865 — VITRO T4-EIA-XT (January 30, 1990)
  • K896864 — FOLLICLE STIMULATING HORMONE-EIA-XT (January 11, 1990)
  • K873832 — REAGENTS FOR USE ON CONTRAVES DC300, DC500, AL801 (November 23, 1987)
  • K871187 — LITHIUM INTERNAL STANDARD 3000 MEQ/L #60084 (May 28, 1987)
  • K871185 — LITHIUM INTERNAL STANDARD 1 MEQ/L #60085 (May 28, 1987)
  • K871184 — FLAME PHOTOMETER STANDARD #60083 160 NA/8K (May 28, 1987)
  • K871186 — CESIUM DILUENT 1.5 MMOL CS/L #60087 (May 28, 1987)

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