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510(k) K842167

TBG RIA by Syncor Intl. Corp. — Product Code CEE

K842167 is an FDA 510(k) premarket notification submitted by Syncor Intl. Corp. for the device "TBG RIA". The FDA issued a decision of Substantially Equivalent on July 9, 1984. The device falls under product code CEE (Radioimmunoassay, Thyroxine-Binding Globulin), a Class II device regulated under 21 CFR 862.1685. Syncor Intl. Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 1984
Date Received
May 31, 1984
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 Syncor Intl. Corp.

  • K945825 — SECURE SAFETY INSERT (April 10, 1995)
  • K851828 — IRRADIATOR FOR BIOLOGICAL MATERIALS IBL-437-C (September 19, 1985)
  • K852023 — CESIUM 137 SOURCE, CSM-4, CSM-11, CSM-41 (August 21, 1985)
  • K850433 — CESIUM 137 ENDOMETRIAL SOURCE (August 21, 1985)
  • K852665 — SYNCOR TRICH DIRECT IMMUNOFLUORESCENCE ASSAY (August 13, 1985)
  • K851033 — SYNCORTECH CHLAMYDIA DIRECT SPECIMAN KIT (June 21, 1985)
  • K844735 — PTH-RIA (April 29, 1985)
  • K850163 — IRIDIUM 192 WIRES (March 26, 1985)
  • K850208 — FLOOD SOURCES & DOSE CALIBRATORS W/VARIOUS NUCLIDS (March 26, 1985)
  • K850434 — CS137 SEALED SOURCES (March 26, 1985)

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