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510(k) K914508

DIMENSION(R) LACTIC ACID METHOD by E.I. Dupont DE Nemours & Co., Inc. — Product Code KHP

K914508 is an FDA 510(k) premarket notification submitted by E.I. Dupont DE Nemours & Co., Inc. for the device "DIMENSION(R) LACTIC ACID METHOD". The FDA issued a decision of Substantially Equivalent on November 27, 1991. The device falls under product code KHP (Acid, Lactic, Enzymatic Method), a Class I device regulated under 21 CFR 862.1450. E.I. Dupont DE Nemours & Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 1991
Date Received
October 9, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Acid, Lactic, Enzymatic Method
Device Class
Class I
Regulation Number
862.1450
Review Panel
CH
Submission Type

Other clearances by E.I. Dupont DE Nemours & Co., Inc.

  • K951851 — ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAY (July 24, 1996)
  • K953724 — CRONEX RADIATION THERAPY CASSETTE (September 6, 1995)
  • K953725 — CRONEX RADIATION THERAPY VERIFICATION CASSETTE (September 6, 1995)
  • K951441 — DUPONT ACA DIGOXIN (DGN A) METHOD (June 1, 1995)
  • K950137 — URINE BARBITURATES SCREEN FLEX(TM) REAGENT CARTRIDGE (April 13, 1995)
  • K950181 — URINE CANNABINOIDS SCREEN FLEX(TM) REAGENT CARTRIDGE (April 5, 1995)
  • K950136 — URINE OPIATES SCREEN FLEX(TM) REAGENT CARTRIDGE (April 5, 1995)
  • K950135 — URINE AMPHETAMINES SCREEN FLEX(TM) REAGENT CARTRIDGE (March 30, 1995)
  • K950427 — URINE BENZODIAZEPINES SCREEN FLEX TEAGENT CARTRIDGE (March 21, 1995)
  • K950134 — URINE COCAINE METABOLITE SCREEN FLEX(TM) REAGENT CATRIDGE (March 21, 1995)

Other clearances for product code KHP

  • K130113 — PICCOLO LACTATE TEST SYSTEM (March 11, 2013)
  • K113216 — RAPIDPOINT 500 BLOOD GAS ANALYER (May 3, 2012)
  • K112955 — NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEM (January 5, 2012)
  • K112430 — I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGE (December 20, 2011)
  • K100602 — NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPS (August 17, 2011)
  • K093297 — EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE (June 9, 2010)
  • K013938 — IRMA SL BLOOD ANALYSIS SYSTEM LACTATE CARTRIDGE (January 28, 2002)
  • K011478 — I-STAT SYSTEM (July 2, 2001)
  • K980908 — LACTATE PRO SYSTEM (September 11, 1998)
  • K982071 — I-STAT LACTATE TEST (June 29, 1998)

FDA data resources