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510(k) K823196

SPECIAL CONTROL SERUM FOR HDL-CHOLES by Boehringer Mannheim Corp. — Product Code JJK

K823196 is an FDA 510(k) premarket notification submitted by Boehringer Mannheim Corp. for the device "SPECIAL CONTROL SERUM FOR HDL-CHOLES". The FDA issued a decision of Substantially Equivalent on November 29, 1982. The device falls under product code JJK (Oncometer, Plasma, For Clinical Use), a Class I device regulated under 21 CFR 862.2720. Boehringer Mannheim Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 1982
Date Received
October 26, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oncometer, Plasma, For Clinical Use
Device Class
Class I
Regulation Number
862.2720
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 JJK

  • K863099 — ABBOTT TESTPACK (TM) ACUTE HEP A CONTROL KIT (September 16, 1986)
  • K802120 — HEPA-SHURE -L (October 20, 1980)
  • K760975 — WEIL ONCOMETER (IL 186) (January 12, 1977)

FDA data resources