EASY-TEST CHEK (INSTRUM. CHECK) & EMDS ABS TEST— 510(k) K861221

Clearance details

Applicant

Em Diagnostic Systems, Inc.

Product code

Code JJX

Device class

Class 1

Regulation

21 CFR 862.1660

Advisory panel

Clinical Chemistry

Date received

1986-04-01

Decision date

1986-04-24

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Gibbstown, NJ, US

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• K935181 — ASPARTATE AMINOTRANSFERASE (AST) TEST1994-01-27
• K935180 — ALANINE AMINOTRANSFERASE (ALT) TEST1994-01-13
• K935178 — EMDS PHOSPHOROUS (PHOS) TEST1993-12-17
• K935179 — EMDS ALBUMIN (ALB) TEST1993-12-17
• K935136 — CHOLESTEROL (CHOL) TEST ITEM NO. 654101993-12-16

Other

2

Total

2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →