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."
121–144 of 288
Search insights Median review: 43d Cleared: 100% Top manufacturer: Em Diagnostic Systems, Inc. Lead specialty: Chemistry
Cleared Aug 17, 1989
AMYLASE TEST (AML) ITEM NUMBER: 65404
K893751 · JFJ
Em Diagnostic Systems, Inc.
Chemistry · 90d
Cleared Aug 15, 1989
CHLORIDE STANDARDS ITEM #SR1041
K891999 · JIT
Em Diagnostic Systems, Inc.
Chemistry · 140d
Cleared Jul 20, 1989
GAMMA GLUTAMYL TRANSFERASE TEST, ITEM: 65414/R1
K893765 · JQB
Em Diagnostic Systems, Inc.
Chemistry · 62d
Cleared Jul 20, 1989
ALANINE AMINOTRANSFERASE TEST (ALT) ITEM # 65403
K893752 · CKA
Em Diagnostic Systems, Inc.
Chemistry · 62d
Cleared Jun 09, 1989
LITHIUM CONCENTRATE #SR1031, NA/K STANDARDS SR1030
K891574 · JGT
Em Diagnostic Systems, Inc.
Chemistry · 81d
Cleared Jun 07, 1989
EASY-TEST IRON (IRON) ITEM NO. 16686
K892863 · JIY
Em Diagnostic Systems, Inc.
Chemistry · 50d
Cleared Mar 31, 1989
REVISED MAGNESIUM TEST ITEM NUMBER: SR1019
K890798 · JGJ
Em Diagnostic Systems, Inc.
Chemistry · 42d
Cleared Feb 17, 1989
BICARBONATE TEST ITEM NUMBER: SR1006
K890305 · KHS
Em Diagnostic Systems, Inc.
Chemistry · 25d
Cleared Feb 17, 1989
CHOLESTEROL TEST ITEM NUMBER: SR1011
K885023 · CHH
Em Diagnostic Systems, Inc.
Chemistry · 74d
Cleared Feb 10, 1989
IRON REAGENTS ITEM NUMBER: SR1017
K890304 · JIY
Em Diagnostic Systems, Inc.
Chemistry · 18d
Cleared Feb 10, 1989
HDL CHOLESTEROL TEST
K885265 · LBR
Em Diagnostic Systems, Inc.
Chemistry · 50d
Cleared Feb 10, 1989
CREATINE KINASE-MB TEST (CK-MK) ITEM NUMBER 65673
K884547 · CGS
Em Diagnostic Systems, Inc.
Chemistry · 102d
Cleared Feb 07, 1989
OLYMPUS TRIGLYCERIDES REAGENTS #SR1021
K885266 · CDT
Em Diagnostic Systems, Inc.
Chemistry · 47d
Cleared Feb 02, 1989
CREATINE KINASE TEST (CK) ITEM NUMBER: 65661
K884546 · CGS
Em Diagnostic Systems, Inc.
Chemistry · 94d
Cleared Jan 30, 1989
DIRECT BILIRUBIN TEST CATALOG NO. SR1008
K885285 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 38d
Cleared Jan 30, 1989
TOTAL BILIRUBIN TEST CATALOG NO. SR1007
K885284 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 38d
Cleared Jan 27, 1989
EASY-TEST PARTIAL THROMBOPLASTIN TIME PTT #16629
K884702 · GFO
Em Diagnostic Systems, Inc.
Hematology · 79d
Cleared Jan 23, 1989
URIC ACID TEST (URIC) ITEM #65620
K884704 · KNK
Em Diagnostic Systems, Inc.
Chemistry · 75d
Cleared Jan 23, 1989
TOTAL PROTEIN TEST (TP) ITEM #65670
K884703 · CEK
Em Diagnostic Systems, Inc.
Chemistry · 75d
Cleared Jan 17, 1989
MAGNESIUM TEST ITEM NUMBER: SR1019
K885022 · JGJ
Em Diagnostic Systems, Inc.
Chemistry · 43d
Cleared Jan 13, 1989
GAMMA GLUTAMYL TRANSFERASE TEST (GGT) ITEM: 65664
K884988 · JQB
Em Diagnostic Systems, Inc.
Chemistry · 43d
Cleared Jan 13, 1989
UREA NITROGEN TEST (BUN) ITEM NUMBER: SR1022
K884987 · CDQ
Em Diagnostic Systems, Inc.
Chemistry · 43d
Cleared Jan 13, 1989
CALCIUM TEST ITEM NUMBER: SR1009
K884986 · CIC
Em Diagnostic Systems, Inc.
Chemistry · 43d
Cleared Jan 11, 1989
CHLORIDE TEST (CL) ITEM #65659
K884706 · CHJ
Em Diagnostic Systems, Inc.
Chemistry · 63d