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510(k) K880787

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

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

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  • K011478 — I-STAT SYSTEM (July 2, 2001)
  • K980908 — LACTATE PRO SYSTEM (September 11, 1998)
  • K982071 — I-STAT LACTATE TEST (June 29, 1998)