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."
25–48 of 288
Search insights Median review: 43d Cleared: 100% Top manufacturer: Em Diagnostic Systems, Inc. Lead specialty: Chemistry
Cleared Feb 23, 1993
SYSTEMATE PLUS CALIBRATOR
K925101 · JIX
Em Diagnostic Systems, Inc.
Chemistry · 138d
Cleared Feb 05, 1993
ABBOTT QUICKSTART LD-1, MODIFICATION
K925188 · JGF
Em Diagnostic Systems, Inc.
Chemistry · 120d
Cleared Feb 05, 1993
LACTATE DEHYDROGENASE (LD) TEST ITEM #65418
K924703 · CFJ
Em Diagnostic Systems, Inc.
Chemistry · 141d
Cleared Jan 28, 1993
CHOLESTEROL TEST ITEM# 42374/93, 42322/R1
K924508 · CHH
Em Diagnostic Systems, Inc.
Chemistry · 146d
Cleared Jan 26, 1993
TRIGLYCERIDES
K924710 · CDT
Em Diagnostic Systems, Inc.
Chemistry · 130d
Cleared Jan 04, 1993
UREA NITROGEN TEST
K925002 · CDQ
Em Diagnostic Systems, Inc.
Chemistry · 94d
Cleared Dec 28, 1992
ALBUMIN TEST
K923959 · CIX
Em Diagnostic Systems, Inc.
Chemistry · 144d
Cleared Dec 03, 1992
BICARBONATE
K924711 · KHS
Em Diagnostic Systems, Inc.
Hematology · 76d
Cleared Nov 25, 1992
EMDS GLUCOSE (GLU-HK) TEST, ITEM 65415
K924572 · CFR
Em Diagnostic Systems, Inc.
Chemistry · 76d
Cleared Nov 09, 1992
EMDS ALKALINE PHOSPHATASE (ALP) TEST
K924574 · CJE
Em Diagnostic Systems, Inc.
Chemistry · 60d
Cleared Nov 06, 1992
SYSTEMATE PLUS TRIGLYCERIDE-GLYCEROL BLANKED TEST
K924573 · CDT
Em Diagnostic Systems, Inc.
Chemistry · 57d
Cleared Oct 26, 1992
CHOLESTEROL TEST
K923733 · CHH
Em Diagnostic Systems, Inc.
Chemistry · 91d
Cleared Oct 15, 1992
CREATININE-IP TEST, # 42375/93, 42323/R1, 42323/R2
K924599 · CGX
Em Diagnostic Systems, Inc.
Chemistry · 34d
Cleared Oct 14, 1992
TWO PART INORGANIC PHOSPHORUS TEST
K924470 · CEO
Em Diagnostic Systems, Inc.
Chemistry · 42d
Cleared Oct 13, 1992
CREATINE KINASE (CK) TEST ITEM #65411
K924704 · CGS
Em Diagnostic Systems, Inc.
Chemistry · 26d
Cleared Sep 28, 1992
EMDS ALANINE AMINOTRANSFER TEST(ALT) TECH RA 1000
K923257 · CKA
Em Diagnostic Systems, Inc.
Chemistry · 88d
Cleared Sep 28, 1992
GAMMA GULTAMYL TRANSFERASE TEST
K922947 · JQB
Em Diagnostic Systems, Inc.
Chemistry · 102d
Cleared Sep 22, 1992
SYSTEMATE URICACID TEST, TECHNICON RA 1000
K923765 · CDO
Em Diagnostic Systems, Inc.
Chemistry · 56d
Cleared Sep 22, 1992
SYSTEMATE PHOSPHORUS TEST TECHNICON RA 1000
K923764 · CEO
Em Diagnostic Systems, Inc.
Chemistry · 56d
Cleared Sep 09, 1992
AMYLASE TEST
K923677 · JFJ
Em Diagnostic Systems, Inc.
Chemistry · 49d
Cleared Sep 09, 1992
SYSTEMATE TOTAL PROTEIN TEST, TECHNICON RA 1000
K923267 · CEK
Em Diagnostic Systems, Inc.
Chemistry · 69d
Cleared Sep 09, 1992
SYSTEMATE CREATININE TEST
K923203 · CGX
Em Diagnostic Systems, Inc.
Chemistry · 76d
Cleared Sep 09, 1992
TOTAL BILIRUBIN CATALOG NO. 65407
K923083 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 76d
Cleared Sep 09, 1992
SYSTEMATE CALCIUM TEST TECHNICON RA 1000
K922953 · CIL
Em Diagnostic Systems, Inc.
Chemistry · 83d