Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

288 results for "Em Diagnostic Systems, Inc."
1–24 of 288
Search insights Median review: 43d Cleared: 100% Top manufacturer: Em Diagnostic Systems, Inc. Lead specialty: Chemistry
Cleared Jan 27, 1994
ASPARTATE AMINOTRANSFERASE (AST) TEST
K935181 · CIT
Em Diagnostic Systems, Inc.
Chemistry · 93d
Cleared Jan 13, 1994
ALANINE AMINOTRANSFERASE (ALT) TEST
K935180 · CKA
Em Diagnostic Systems, Inc.
Chemistry · 79d
Cleared Dec 17, 1993
EMDS ALBUMIN (ALB) TEST
K935179 · CIX
Em Diagnostic Systems, Inc.
Chemistry · 52d
Cleared Dec 17, 1993
EMDS PHOSPHOROUS (PHOS) TEST
K935178 · CEO
Em Diagnostic Systems, Inc.
Chemistry · 52d
Cleared Dec 16, 1993
GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST
K935177 · JQB
Em Diagnostic Systems, Inc.
Chemistry · 51d
Cleared Dec 16, 1993
IRON TEST
K935176 · JIY
Em Diagnostic Systems, Inc.
Chemistry · 50d
Cleared Dec 16, 1993
LACTATE DEHYDROGENASE (LD)
K935175 · CFJ
Em Diagnostic Systems, Inc.
Chemistry · 50d
Cleared Dec 16, 1993
TOTAL PROTEIN TEST (TPRO)
K935174 · CEK
Em Diagnostic Systems, Inc.
Chemistry · 50d
Cleared Dec 16, 1993
CHOLESTEROL (CHOL) TEST ITEM NO. 65410
K935136 · CHH
Em Diagnostic Systems, Inc.
Chemistry · 49d
Cleared Dec 09, 1993
EMDS MAGNESIUM (MG) TEST
K935183 · JGJ
Em Diagnostic Systems, Inc.
Chemistry · 43d
Cleared Dec 09, 1993
EMDS ALKANINE PHOSPHATASE (ALP) TEST
K935182 · CJE
Em Diagnostic Systems, Inc.
Chemistry · 43d
Cleared Sep 27, 1993
URIC ACID TEST ITEM NUMBER 65422
K932162 · CDO
Em Diagnostic Systems, Inc.
Chemistry · 146d
Cleared Sep 27, 1993
CALCIUM TEST ITEM NUMBER 65409
K932158 · CIC
Em Diagnostic Systems, Inc.
Chemistry · 146d
Cleared Sep 21, 1993
SYSTEMATE DIRECT BILIRUBIN CAT. NO. 65406
K932159 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 140d
Cleared Sep 08, 1993
UREA NITROGEN TEST ITEM NUMBER 65408
K932161 · CDQ
Em Diagnostic Systems, Inc.
Chemistry · 127d
Cleared Aug 25, 1993
TRIGLYCERIDES
K931891 · CDT
Em Diagnostic Systems, Inc.
Chemistry · 132d
Cleared Aug 19, 1993
SILYL AMYL
K931583 · JFJ
Em Diagnostic Systems, Inc.
Chemistry · 141d
Cleared Aug 19, 1993
ETHYLIDENE AMYL
K931582 · JFJ
Em Diagnostic Systems, Inc.
Chemistry · 141d
Cleared Aug 03, 1993
BICARBONATE
K931887 · KHS
Em Diagnostic Systems, Inc.
Chemistry · 110d
Cleared Jul 27, 1993
CREATINE KINASE TEST
K931889 · CGS
Em Diagnostic Systems, Inc.
Chemistry · 103d
Cleared Jul 27, 1993
TOTAL BILIRUBIN
K931888 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 103d
Cleared Jul 22, 1993
GLUCOSE-HK TEST
K931890 · CFR
Em Diagnostic Systems, Inc.
Chemistry · 98d
Cleared Jul 09, 1993
SYSTEMATE CREATININE TEST ITEM NUMBER 65413
K932160 · CGX
Em Diagnostic Systems, Inc.
Chemistry · 66d
Cleared Apr 21, 1993
IRON TEST #'S 42376/93,42324/R1A,42324/R1B,42324/R
K930166 · JIY
Em Diagnostic Systems, Inc.
Chemistry · 98d