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510(k) K862762

TINA-QUANT(R) IGM by Boehringer Mannheim Corp. — Product Code DFT

K862762 is an FDA 510(k) premarket notification submitted by Boehringer Mannheim Corp. for the device "TINA-QUANT(R) IGM". The FDA issued a decision of Substantially Equivalent on September 8, 1986. The device falls under product code DFT (Igm, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5550. Boehringer Mannheim Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 1986
Date Received
July 22, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Igm, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5550
Review Panel
IM
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 DFT

  • K983132 — IGM (November 4, 1998)
  • K962201 — QUANTEX IGM (September 25, 1996)
  • K955797 — IGM IMMUNOTRUBIDIMETRIC & CALIBRATOR (April 5, 1996)
  • K945522 — I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLS (December 12, 1994)
  • K901453 — QUIK-SEP(R) IGM RPROTEIN G AFFINITY METHOD (April 12, 1990)
  • K894417 — RAICHEM(TM) SPIA(TM) IGM REAGENTS (August 2, 1989)
  • K884147 — IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN M (October 27, 1988)
  • K880828 — WAKO(TM) IGM-HA DIRECT (March 25, 1988)
  • K873871 — IMMUNOGLOBULINS M (October 13, 1987)
  • K872237 — KALLESTAD QM300 IGM ANTIBODY PACK (July 9, 1987)

FDA data resources