EMDS ACETAMINOPHEN CALIBRATOR NO. 67636/95— 510(k) K882766

Name: FDA 510(k) clearance K882766
Creator: U.S. Food and Drug Administration
Published: 1988-08-23

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K882766 for EMDS ACETAMINOPHEN CALIBRATOR NO. 67636/95, Substantially Equivalent on 1988-08-23. Applicant: Em Diagnostic Systems, Inc.. Device class: 1.

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code DLG
Device class: Class 1
Regulation: 21 CFR 862.2250
Advisory panel: Clinical Chemistry
Date received: 1988-07-06
Decision date: 1988-08-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DLG

view all

K050988 — OPIATE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS2006-04-06
K920419 — IL TEST DAT CAL/CONTROL SET D/E1992-03-11
K894518 — FPR AMIKACIN CALIBRATOR KIT1989-09-28
K894524 — FPR GENTAMICIN CALIBRATOR KIT1989-09-28
K894528 — FPR PHENYTOIN CALIBRATOR KIT1989-09-25

More clearances from Em Diagnostic Systems, Inc.

view all

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.