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510(k) K810967

IN-VITRO TBG RADIOIMMUNOASSAY TEST by Clinical Assays, Inc. — Product Code CEE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 1981
Date Received
April 8, 1981
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 Clinical Assays, Inc.

  • K832710 — VITAMIN B12 RADIOASSAY KIT CA-1534 (October 4, 1983)
  • K832711 — VITAMIN B12 FOLATE CA-1515-125 (October 4, 1983)
  • K832712 — FOLATE RADIOASSAY KIT CA-1562-125 (October 4, 1983)
  • K823476 — GAMMADAB LH RADIO-KIT #CA-1508 (December 28, 1982)
  • K823313 — IN VITRO GAMMACOAT B-HCG RADIO. TEST (December 22, 1982)
  • K821611 — GAMMADAB [125] FSH RADIOIMMUNAY KIT (June 24, 1982)
  • K821092 — GAMMADAB[125]EGE RADIOIMMUNOASSAY IT (June 22, 1982)
  • K812227 — GAMMACOAT (125) INSULIN RADIOIMMUNOASSAY (September 24, 1981)
  • K810722 — GASTRIN RADIOIMMUNOASSAY TEST (May 27, 1981)
  • K801667 — GAMMA COAT(125 I) RUBELLA ANTIBODY (October 23, 1980)

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)