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510(k) K955908

BOEHRINGER MANNHEIM IGM ASSAY by Boehringer Mannheim Corp. — Product Code DAO

K955908 is an FDA 510(k) premarket notification submitted by Boehringer Mannheim Corp. for the device "BOEHRINGER MANNHEIM IGM ASSAY". The FDA issued a decision of Substantially Equivalent on February 9, 1996. The device falls under product code DAO (Igm (Mu Chain Specific), 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
February 9, 1996
Date Received
December 29, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Igm (Mu Chain Specific), 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 DAO

  • K040431 — ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2 (March 10, 2004)
  • K982639 — SPIFE URINE IFE (November 4, 1998)
  • K850586 — SPQ TEST SYSTEM FOR IMMUNOGLOBULIN M (March 14, 1985)
  • K841992 — MODIFICATION TO ACS CORONARY GUIDING (June 11, 1984)
  • K812487 — IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGM (September 23, 1981)
  • K800450 — GEMENI IGM ASSAY (April 24, 1980)
  • K790705 — ANTISERUM TO HUMAN IGM (April 12, 1979)

FDA data resources