FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

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