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."
97–120 of 288
Search insights Median review: 43d Cleared: 100% Top manufacturer: Em Diagnostic Systems, Inc. Lead specialty: Chemistry
Cleared Jun 06, 1990
SYSTEMATE(TM) DIRECT BILIRUBIN CATALOG NO. 65406
K902123 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 26d
Cleared May 10, 1990
OLYMPUS(TM) TOTAL BILIRUBIN
K897174 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 134d
Cleared May 02, 1990
OLYMPUS INORGANIC PHOSPHORUS (2-REAGENT MODIFICA.)
K901807 · CEO
Em Diagnostic Systems, Inc.
Chemistry · 12d
Cleared Apr 16, 1990
EMDS(TM) CEREBROSPINAL FLUID PROTEIN, #67668/95
K901083 · JGQ
Em Diagnostic Systems, Inc.
Chemistry · 40d
Cleared Mar 29, 1990
EMDS CHOLESTEROL (CHO), ITEM NUMBERS 65410
K900850 · CHH
Em Diagnostic Systems, Inc.
Chemistry · 35d
Cleared Mar 19, 1990
SYSTEMATE(TM) TOTAL BILIRUBIN CATALOG NO. 654XX
K897176 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 82d
Cleared Mar 15, 1990
OLYMPUS DIRECT BILIRUBIN
K897175 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 78d
Cleared Oct 31, 1989
SYSTEMATE(TM) ALKALINE PHOSPHATASE ITEM #65402
K895250 · CJE
Em Diagnostic Systems, Inc.
Chemistry · 71d
Cleared Oct 31, 1989
SYSTEMATE(TM) IRON ITEM NUMBER: 65417
K895249 · JIY
Em Diagnostic Systems, Inc.
Chemistry · 71d
Cleared Oct 23, 1989
SYSTEMATE CREATININE TEST (CREA) #65413
K895022 · CGX
Em Diagnostic Systems, Inc.
Chemistry · 76d
Cleared Oct 17, 1989
SYSTEMATE DIRECT BILIRUBIN CATALOG NO. 65406
K895119 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 63d
Cleared Oct 17, 1989
SYSTEMATE TOTAL BILIRUBIN CATALOG NO. 65407
K895118 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 63d
Cleared Sep 15, 1989
BICARBONATE TEST ITEM NUMBER: 65412
K894509 · KHS
Em Diagnostic Systems, Inc.
Chemistry · 58d
Cleared Sep 07, 1989
GLUCOSE-HK TEST (GLU-HK) ITEM #65415
K894483 · CFR
Em Diagnostic Systems, Inc.
Chemistry · 51d
Cleared Sep 07, 1989
LACTATE DEHYDROGENASE TEST (LD) ITEM #65418
K894482 · CFJ
Em Diagnostic Systems, Inc.
Chemistry · 51d
Cleared Sep 05, 1989
CALCIUM TEST ITEM NUMBER: 65409
K893778 · CIC
Em Diagnostic Systems, Inc.
Chemistry · 106d
Cleared Aug 31, 1989
MAGNESIUM TEST ITEM NUMBER: 65419
K894508 · JGJ
Em Diagnostic Systems, Inc.
Chemistry · 43d
Cleared Aug 31, 1989
UREA NITROGEN TEST (BUN) ITEM #65408
K894378 · CDQ
Em Diagnostic Systems, Inc.
Chemistry · 45d
Cleared Aug 31, 1989
PHOSPHORUS TEST ITEM NUMBER 65416
K894288 · CED
Em Diagnostic Systems, Inc.
Chemistry · 69d
Cleared Aug 31, 1989
EMDS TOTAL PROTEIN (TP), ITEM NUMBER 65420
K893915 · CEK
Em Diagnostic Systems, Inc.
Chemistry · 93d
Cleared Aug 28, 1989
URIC ACID TEST ITEM NUMBER 65422
K894287 · KNK
Em Diagnostic Systems, Inc.
Chemistry · 66d
Cleared Aug 28, 1989
EMDS TRIGLYCERIDE (TRIG), ITEM NUMBER 65421
K893917 · CDT
Em Diagnostic Systems, Inc.
Chemistry · 90d
Cleared Aug 28, 1989
EMDS CHOLESTEROL (CHO), ITEM NUMBER 65410
K893916 · CHH
Em Diagnostic Systems, Inc.
Chemistry · 90d
Cleared Aug 21, 1989
ALBUMIN TEST (ALB) ITEM NUMBER: 65401
K893777 · CIX
Em Diagnostic Systems, Inc.
Chemistry · 91d