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."
145–168 of 288
Search insights Median review: 43d Cleared: 100% Top manufacturer: Em Diagnostic Systems, Inc. Lead specialty: Chemistry
Cleared Jan 11, 1989
ALBUMIN TEST (ALB) ITEM #65650
K884705 · CIX
Em Diagnostic Systems, Inc.
Chemistry · 63d
Cleared Jan 11, 1989
AMYLASE TEST (AMYL) ITEM NUMBER: 65653
K884382 · CIW
Em Diagnostic Systems, Inc.
Chemistry · 85d
Cleared Jan 11, 1989
ALANINE AMINOTRANSFERASE TEST ITEM NO. 65652
K884376 · CKA
Em Diagnostic Systems, Inc.
Chemistry · 85d
Cleared Jan 03, 1989
GLUCOSE-HK TEST (GLUC-HK) ITEM #65665
K884736 · CFR
Em Diagnostic Systems, Inc.
Chemistry · 50d
Cleared Dec 19, 1988
CREATININE TEST (CREA) ITEM #65663
K884734 · CGX
Em Diagnostic Systems, Inc.
Chemistry · 35d
Cleared Dec 16, 1988
PHOSPHORUS TEST (PHOS) ITEM #65666
K884735 · CEO
Em Diagnostic Systems, Inc.
Chemistry · 32d
Cleared Dec 14, 1988
ASPARTATE AMINOTRANSFERASE TEST ITEM NO. 65654
K884377 · CIT
Em Diagnostic Systems, Inc.
Chemistry · 57d
Cleared Nov 10, 1988
ALKALINE PHOSPHATASE TEST (ALP) ITEM NO. 65651
K884549 · CJE
Em Diagnostic Systems, Inc.
Chemistry · 10d
Cleared Nov 10, 1988
LACTATE DEHYDROGENASE TEST (LD) ITEM NO. 65668
K884548 · CFJ
Em Diagnostic Systems, Inc.
Chemistry · 10d
Cleared Nov 10, 1988
EMDS GLUCOSE (GLUC) TESTPACKS, NO. 67697/95
K884021 · CFR
Em Diagnostic Systems, Inc.
Chemistry · 49d
Cleared Aug 23, 1988
EMDS ACETAMINOPHEN CALIBRATOR NO. 67636/95
K882766 · DLG
Em Diagnostic Systems, Inc.
Toxicology · 48d
Cleared Aug 08, 1988
EASY-TEST EMIT ACETAMINOPHEN (ACTM) NO. 16653
K882719 · LDP
Em Diagnostic Systems, Inc.
Toxicology · 38d
Cleared Jun 01, 1988
EASY-TEST EMIT(R) ETHOSUXIMIDE (ETHS) ITEM 16647
K881607 · DLF
Em Diagnostic Systems, Inc.
Toxicology · 50d
Cleared May 27, 1988
EMDS LIDOCAINE CALIBRATOR ITEM NO. 67XXX/95
K881337 · DLJ
Em Diagnostic Systems, Inc.
Toxicology · 59d
Cleared May 27, 1988
AUTO TROL(TM) CONTROL, LEVELS 1 & 2 #16692 & 16693
K881229 · JJY
Em Diagnostic Systems, Inc.
Chemistry · 66d
Cleared Mar 11, 1988
ADDITIONAL ALLERGENS FOR IGE FAST-PLUS TEST
K880003 · DHB
Em Diagnostic Systems, Inc.
Immunology · 67d
Cleared Feb 25, 1988
EASY-TEST POTASSIUM K ITEM NUMBER 19XXX
K880339 · CEJ
Em Diagnostic Systems, Inc.
Chemistry · 30d
Cleared Feb 11, 1988
EASY-TEST PROTHROMBIN TIME PT ITEM NO. 16628
K875062 · GJS
Em Diagnostic Systems, Inc.
Hematology · 64d
Cleared Jan 21, 1988
EASY-TEST ASPARTATE AMINOTRANSFERASE (ASAT) #19010
K874600 · CIT
Em Diagnostic Systems, Inc.
Chemistry · 73d
Cleared Jan 21, 1988
EASY-TEST ALANINE AMINOTRANSFERASE (ALAT) #19017
K874586 · CKA
Em Diagnostic Systems, Inc.
Chemistry · 73d
Cleared Dec 22, 1987
EASY-TEST AMYLASE (AMYL), ITEM NUMBER 19019
K874705 · JEJ
Em Diagnostic Systems, Inc.
Chemistry · 33d
Cleared Dec 18, 1987
EASY-TEST GLUCOSE (GLUC), ITEM NUMBER 19008
K874708 · LFR
Em Diagnostic Systems, Inc.
Chemistry · 29d
Cleared Nov 25, 1987
EASY-TEST TOTAL PROTEIN (TP) ITEM NUMBER: 19011
K874476 · CEK
Em Diagnostic Systems, Inc.
Chemistry · 23d
Cleared Nov 24, 1987
EASY-TEST HDL CHOLESTEROL ITEM NUMBER 16683
K874397 · LBS
Em Diagnostic Systems, Inc.
Chemistry · 27d