510(k) K860641

EASY-TEST (CHE) REAGENT, ITEM NO. 67522/93 by Em Diagnostic Systems, Inc. — Product Code DLI

K860641 is an FDA 510(k) premarket notification submitted by Em Diagnostic Systems, Inc. for the device "EASY-TEST (CHE) REAGENT, ITEM NO. 67522/93". The FDA issued a decision of Substantially Equivalent on April 3, 1986. The device falls under product code DLI (Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase), a Class I device regulated under 21 CFR 862.3240. Em Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: April 3, 1986
Date Received: February 20, 1986
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase
Device Class: Class I
Regulation Number: 862.3240
Review Panel: TX
Submission Type

Other clearances by Em Diagnostic Systems, Inc.

K935181 — ASPARTATE AMINOTRANSFERASE (AST) TEST (January 27, 1994)
K935180 — ALANINE AMINOTRANSFERASE (ALT) TEST (January 13, 1994)
K935178 — EMDS PHOSPHOROUS (PHOS) TEST (December 17, 1993)
K935179 — EMDS ALBUMIN (ALB) TEST (December 17, 1993)
K935175 — LACTATE DEHYDROGENASE (LD) (December 16, 1993)
K935136 — CHOLESTEROL (CHOL) TEST ITEM NO. 65410 (December 16, 1993)
K935176 — IRON TEST (December 16, 1993)
K935177 — GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST (December 16, 1993)
K935174 — TOTAL PROTEIN TEST (TPRO) (December 16, 1993)
K935183 — EMDS MAGNESIUM (MG) TEST (December 9, 1993)

510(k) K860641

Clearance Details

Device Classification

Other clearances by Em Diagnostic Systems, Inc.

Other clearances for product code DLI

FDA data resources