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510(k) K951750

GLUCOSE TEST ITEM NUMBER 97375/94 by Emd Chemicals, Inc. — Product Code LFR

K951750 is an FDA 510(k) premarket notification submitted by Emd Chemicals, Inc. for the device "GLUCOSE TEST ITEM NUMBER 97375/94". The FDA issued a decision of Substantially Equivalent on September 6, 1995. The device falls under product code LFR (Glucose Dehydrogenase, Glucose), a Class II device regulated under 21 CFR 862.1345. Emd Chemicals, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 1995
Date Received
April 17, 1995
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 Emd Chemicals, Inc.

  • K031367 — DUOPATH VEROTOXINS GLISA TEST (January 23, 2004)
  • K990516 — ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS (March 31, 1999)
  • K981926 — ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS (July 22, 1998)
  • K973054 — ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS (October 1, 1997)
  • K951494 — AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR) (December 11, 1995)
  • K950234 — TOTAL PROTEIN TEST (TPRO) ITEM NUMBER: XXXXX/R1. R2 (June 14, 1995)
  • K950128 — TOTAL PROTEIN TEST (TPRO) ITEM XXXXX/R1. R2 (May 15, 1995)
  • K945322 — PHOSPHORUS TEST (PHOS) ITEM NUMBER 65416 (December 7, 1994)
  • K945368 — PHOSPHORUS TEST (PHOS) (December 2, 1994)
  • K840883 — UNIPAK 100 ANALYZER, 65156 & CHEMISTR (May 16, 1984)

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