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510(k) K862109

ENZYMUN TEST TBG by Boehringer Mannheim Corp. — Product Code CEE

K862109 is an FDA 510(k) premarket notification submitted by Boehringer Mannheim Corp. for the device "ENZYMUN TEST TBG". The FDA issued a decision of Substantially Equivalent on June 30, 1986. The device falls under product code CEE (Radioimmunoassay, Thyroxine-Binding Globulin), a Class II device regulated under 21 CFR 862.1685. Boehringer Mannheim Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 1986
Date Received
June 3, 1986
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 Boehringer Mannheim Corp.

  • K984326 — ELECYS IGE ASSAY (February 8, 1999)
  • K983047 — ACCU-CHEK HQ SYSTEM (February 5, 1999)
  • K984419 — ELECSYS IGE CALCHECK (February 2, 1999)
  • K984425 — MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATOR (January 20, 1999)
  • K984372 — ELECSYS CALCHECK TROPONIN T (December 14, 1998)
  • K984105 — ELECSYS TROPONIN T STAT TEST (December 8, 1998)
  • K983503 — ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT (December 1, 1998)
  • K983469 — PRECISET SERUM PROTEINS CALIBRATOR (November 25, 1998)
  • K983185 — BOEHRINGER MANNHEIM TINA-QUANT IGE TEST (November 12, 1998)
  • K982948 — ELECSYS PSA, MODEL # ELECSYS 1010 (October 27, 1998)

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