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510(k) K982002

ACCU-CHEK COMFORT CURVE TEST STRIP by Boehringer Mannheim Corp. — Product Code LFR

K982002 is an FDA 510(k) premarket notification submitted by Boehringer Mannheim Corp. for the device "ACCU-CHEK COMFORT CURVE TEST STRIP". The FDA issued a decision of Substantially Equivalent on September 2, 1998. The device falls under product code LFR (Glucose Dehydrogenase, Glucose), a Class II device regulated under 21 CFR 862.1345. Boehringer Mannheim Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 1998
Date Received
June 8, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Glucose Dehydrogenase, Glucose
Device Class
Class II
Regulation Number
862.1345
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)
  • K982949 — ELECSYS PSA, MODEL 2010 (October 27, 1998)

Other clearances for product code LFR

  • K152328 — FreeStyle InsuLinx Blood Glucose Monotioring System (September 17, 2015)
  • K142089 — ACCU-CHEK AVIVA EXPERT SYSTEM (December 17, 2014)
  • K133537 — EGV1.1 SELF MONITORING BLOOD GLUCOSE SYSTEM AND EGV1.1 PRO MONITORING BLOOD GLUC (April 28, 2014)
  • K131727 — CERA-CHEK 1070 BLOOD GLUCOSE MONITORING SYSTEM (February 28, 2014)
  • K131366 — ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM (October 11, 2013)
  • K122688 — NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITOR (April 4, 2013)
  • K121433 — GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) (February 14, 2013)
  • K122435 — NOVA ONE BLOOD GLUCOSE MONITOR (December 20, 2012)
  • K113314 — PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM (November 9, 2012)
  • K121224 — GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEM (September 19, 2012)

FDA data resources