Home / 510(k) Clearances / K780671

510(k) K780671

125 I-T3 UPTAKE REAGENT by Radioimmunoassay, Inc. — Product Code CEE

K780671 is an FDA 510(k) premarket notification submitted by Radioimmunoassay, Inc. for the device "125 I-T3 UPTAKE REAGENT". The FDA issued a decision of Substantially Equivalent on June 6, 1978. The device falls under product code CEE (Radioimmunoassay, Thyroxine-Binding Globulin), a Class II device regulated under 21 CFR 862.1685. Radioimmunoassay, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 1978
Date Received
April 24, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Thyroxine-Binding Globulin
Device Class
Class II
Regulation Number
862.1685
Review Panel
CH
Submission Type

Other clearances by Radioimmunoassay, Inc.

  • K802135 — TESTOSTERONE RADIOIMMUNOASSY KIT (October 10, 1980)
  • K800107 — FOLLICLE STIMULATING HORMONE (February 13, 1980)
  • K800106 — LUTEINIZING HORMONE RADIOIMMUNOASSAY SYS (February 13, 1980)
  • K792539 — TRIIODOTHYRONINE RIA SYSTEM (January 16, 1980)
  • K792153 — DIGOXIN RADIOIMMUNOASSAY SYSTEM (November 13, 1979)
  • K792154 — THYROID STIMULATING HORMONE (November 13, 1979)
  • K792036 — CORTISOL RADIOIMMUNOASSAY SYSTEM (October 30, 1979)
  • K780672 — 125 I-T4 RIA REAGENT (June 6, 1978)

Other clearances for product code CEE

  • K952284 — AMERLITE TBG ASSAY (July 26, 1995)
  • K930010 — ACCESS THYROID UPTAKE ASSAY (June 7, 1993)
  • K910677 — IMMULITE(TM) T-UPTAKE (April 29, 1991)
  • K905777 — MICROZYME THYROID UPTAKE ENZYME IMMUNOASSAY KIT (January 30, 1991)
  • K900240 — DELFIA TBG KIT (March 30, 1990)
  • K896991 — ENZYMUN TEST(R) TBK (March 1, 1990)
  • K893469 — AMERLITE TBG ASSAY, LAN.0005/1005 240/144 TEST KIT (August 15, 1989)
  • K885034 — T-UPTAKE MICROASSAY (February 2, 1989)
  • K884201 — FIAGEN TBG TIME-RESOLVED FLUOROIMMUNOASSAY KIT (December 14, 1988)
  • K874658 — TECHNICON RA(R) ANALYTE (TBG) (30 C AND 37 C) (December 18, 1987)

FDA data resources