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510(k) K884168

ANALYST THYROXINE (T4) & THYRONINE UPTAKE CALIBRA. by The DU Pont Co. — Product Code JIS

K884168 is an FDA 510(k) premarket notification submitted by The DU Pont Co. for the device "ANALYST THYROXINE (T4) & THYRONINE UPTAKE CALIBRA.". The FDA issued a decision of Substantially Equivalent on November 29, 1988. The device falls under product code JIS (Calibrator, Primary), a Class II device regulated under 21 CFR 862.1150. The DU Pont Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 1988
Date Received
October 4, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Primary
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

Other clearances by The DU Pont Co.

  • K953475 — CDS COMPACT DAYLIGHT CASSETTE FOR VIDEO IMAGING (October 7, 1995)
  • K953477 — MODULAR DAYLIGHT CASSETTE FOR VIDEO IMAGING (October 7, 1995)
  • K952891 — CRONEX LOW ABSORPTION CASSETTE (July 13, 1995)
  • K945125 — DUPONT ACA VANCOMYCIN (VANC) METHOD (March 10, 1995)
  • K943704 — LIPASE CALIBRATOR (September 14, 1994)
  • K900492 — LABELING CHANGE - VIASPAN(TM) (BELZER UW) (March 20, 1990)
  • K885258 — ACA THYROXINE (T4 E) METHOD (February 17, 1989)
  • K885259 — ACA THYRONINE UPTAKE (TU E) METHOD (February 17, 1989)
  • K884700 — ANALYST THYROXINE (T4) ROTOR (January 27, 1989)
  • K884169 — DU PONT ANALYST THYROID ROTOR (January 24, 1989)

Other clearances for product code JIS

  • K122126 — DIRECT LDL/HDL CHOLESTEROL CALIBRATOR (August 14, 2012)
  • K061251 — DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATOR (May 31, 2006)
  • K060266 — DIMENSION IRON CALIBRATOR (March 9, 2006)
  • K053104 — DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATOR (December 23, 2005)
  • K032697 — DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414) (November 7, 2003)
  • K032608 — GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETER (October 21, 2003)
  • K032296 — VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTRONE REAGENT PACK AND CALIBRATORS (August 13, 2003)
  • K030964 — CALIBRATION PLASMA LMW HEPARIN (June 6, 2003)
  • K030546 — CRP (II) CALIBRATORS (June 2, 2003)
  • K030320 — WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, MICRO ALBUMIN CON (April 11, 2003)

FDA data resources