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510(k) K893469

AMERLITE TBG ASSAY, LAN.0005/1005 240/144 TEST KIT by Amersham Corp. — Product Code CEE

K893469 is an FDA 510(k) premarket notification submitted by Amersham Corp. for the device "AMERLITE TBG ASSAY, LAN.0005/1005 240/144 TEST KIT". The FDA issued a decision of Substantially Equivalent on August 15, 1989. The device falls under product code CEE (Radioimmunoassay, Thyroxine-Binding Globulin), a Class II device regulated under 21 CFR 862.1685. Amersham Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 1989
Date Received
May 4, 1989
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 Amersham Corp.

  • K914135 — AMERLITE(TM) PROLACTIN-30 ASSAY, LAN.0086/2086 (February 18, 1992)
  • K912733 — AMERLEX-M SPECIFIC ESTROL(UNCONJUGATED) RIA KIT (July 22, 1991)
  • K912766 — AMERLITE CK-MB ASSAY (July 17, 1991)
  • K904666 — AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/2008 (November 2, 1990)
  • K902760 — AMERSHAM TSH CONTROL SERA (July 27, 1990)
  • K901854 — GADOLINIUM-153 BONE DENSITOMETER (GDC.10411/10412) (July 9, 1990)
  • K901848 — GADOLINIUM-153 BONE DENSITOMETER SOURCES (July 9, 1990)
  • K901857 — GADOLINIUM-153 BONE DENSITOMETER (GDC.10413) (July 9, 1990)
  • K901832 — GADOLINIUM-153 BONE DENSITOMETER SOURCES GDC.10415 (July 9, 1990)
  • K896270 — AMERLITE ESTRADIOL-60 ASSAY LAN.0081/2081 (December 12, 1989)

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)
  • 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)
  • K862109 — ENZYMUN TEST TBG (June 30, 1986)

FDA data resources