Home / 510(k) Clearances / K880787

510(k) K880787

EASY-TEST LACTIC ACID (LA) by Diagnostic Systems — Product Code KHP

K880787 is an FDA 510(k) premarket notification submitted by Diagnostic Systems for the device "EASY-TEST LACTIC ACID (LA)". The FDA issued a decision of Substantially Equivalent on March 15, 1988. The device falls under product code KHP (Acid, Lactic, Enzymatic Method), a Class I device regulated under 21 CFR 862.1450. Diagnostic Systems has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 1988
Date Received
February 26, 1988
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 Diagnostic Systems

  • K905146 — OLYMPUS URINE PH (February 4, 1991)
  • K893691 — EMDS CREATINE KINASE ITEM NIMBER 65411 (August 31, 1989)
  • K893692 — EMDS ASPARTATE AMINOTRANSFERASE ITEM NUMBER 65405 (August 21, 1989)
  • K893966 — HDL PRECIPITATING REAGENT (July 25, 1989)
  • K884993 — VISUAL BLOOD GLUCOSE TEST SYSTEM (December 29, 1988)
  • K881116 — EASY-TEST EMIT(R) LIDOCAINE LIDO ITEM NO. 16641 (June 20, 1988)
  • K862403 — EMDS ANTIEPILEPTIC DRUG CALIBRATORS ITEM #67630/95 (July 11, 1986)
  • K854784 — ABSORBANCE (ABS) TEST PAK (December 19, 1985)
  • K853699 — EASY ANALYZER & EASY-TEST REAGENT (September 25, 1985)
  • K853533 — ABSORBANCE TEST SOLUTION (September 16, 1985)

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