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."
241–264 of 288
Search insights Median review: 43d Cleared: 100% Top manufacturer: Em Diagnostic Systems, Inc. Lead specialty: Chemistry
Cleared May 23, 1986
EMDS, CK/CK-MB VERIFIER, ITEM NUMBER 67---/95
K861512 · JJT
Em Diagnostic Systems, Inc.
Chemistry · 30d
Cleared May 23, 1986
EMDS AMYLASE (AMYL) TEST PACKS, # 67653/95
K860935 · CIJ
Em Diagnostic Systems, Inc.
Chemistry · 72d
Cleared Apr 24, 1986
EASY-TEST CHEK (INSTRUM. CHECK) & EMDS ABS TEST
K861221 · JJX
Em Diagnostic Systems, Inc.
Chemistry · 23d
Cleared Apr 24, 1986
EMDS CREATINE KINASE ISOENZYME CKMB TEST PACK
K861061 · CGS
Em Diagnostic Systems, Inc.
Chemistry · 35d
Cleared Apr 24, 1986
EASY-TEST ISE CALIBRATOR, ITEM NO. 67566/95
K861055 · JJE
Em Diagnostic Systems, Inc.
Chemistry · 36d
Cleared Apr 09, 1986
EASY-TEST (GGT) REAGENT, ITEM NO. 67526/93
K860640 · JQB
Em Diagnostic Systems, Inc.
Chemistry · 48d
Cleared Apr 07, 1986
EASY-TEST TOTAL PROTEIN (TP), #67513/93
K860917 · CEK
Em Diagnostic Systems, Inc.
Chemistry · 27d
Cleared Apr 07, 1986
EASY-TEST URIC ACID (URIC), #67516/93
K860916 · KNK
Em Diagnostic Systems, Inc.
Chemistry · 27d
Cleared Apr 07, 1986
EMDS CHEMISTRY CALIBRATORS, LEVELS I & II
K860765 · JIX
Em Diagnostic Systems, Inc.
Chemistry · 35d
Cleared Apr 07, 1986
EMDS ENZYME VERIFIER, LEVELS I & II
K860764 · JJT
Em Diagnostic Systems, Inc.
Chemistry · 35d
Cleared Apr 07, 1986
CREATINE KINASE, N-ACETYL-L-CYSTIENE
K860669 · CGS
Em Diagnostic Systems, Inc.
Chemistry · 42d
Cleared Apr 07, 1986
ION-SPECIFIC ELECTRODE, CHLORIDE
K860668 · CGZ
Em Diagnostic Systems, Inc.
Chemistry · 42d
Cleared Apr 03, 1986
EASY-TEST AMLASE (AMYL), #67521/93
K860918 · JFJ
Em Diagnostic Systems, Inc.
Chemistry · 23d
Cleared Apr 03, 1986
EASY-TEST (CHE) REAGENT, ITEM NO. 67522/93
K860641 · DLI
Em Diagnostic Systems, Inc.
Chemistry · 42d
Cleared Mar 05, 1986
NEONATAL BILIRUBIN(NBIL) TEST PACK 67661/95
K855079 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 76d
Cleared Feb 21, 1986
EASY-TEST UREA (BUN) REAGENT
K860135 · CDQ
Em Diagnostic Systems, Inc.
Chemistry · 38d
Cleared Feb 11, 1986
EMDS GLUCOSE TEST PACK ITEM 67656/95
K855080 · LFR
Em Diagnostic Systems, Inc.
Chemistry · 54d
Cleared Feb 06, 1986
EASY-TEST ALKALINE PHOSPHATASE (ALP) REAGENT
K860134 · CJE
Em Diagnostic Systems, Inc.
Chemistry · 23d
Cleared Jan 22, 1986
EMDS TOTAL CK TEST PACK-#67670/95
K855056 · CGS
Em Diagnostic Systems, Inc.
Chemistry · 35d
Cleared Dec 05, 1985
ULTRAZYME PLUS & SYSTEMATE LDH
K854585 · CFJ
Em Diagnostic Systems, Inc.
Chemistry · 17d
Cleared Aug 21, 1985
UNI PAK 500 ANALYZER + CHEMISTRY REAGENT ITEM
K852481 · JJQ
Em Diagnostic Systems, Inc.
Chemistry · 71d
Cleared Jul 15, 1985
MICROSPIN MINICENTRIFUGE ITEM NO. 65204/94
K852482 · JPI
Em Diagnostic Systems, Inc.
Microbiology · 34d
Cleared Jul 12, 1985
SYSTEMATE CK-MB(NAC-ACTIVATED) ITEM NO. 67205
K852483 · CGS
Em Diagnostic Systems, Inc.
Chemistry · 31d
Cleared Jun 25, 1985
PREGNANCY CARD TEST
K852066 · JHJ
Em Diagnostic Systems, Inc.
Chemistry · 46d