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."
265–288 of 288
Search insights Median review: 43d Cleared: 100% Top manufacturer: Em Diagnostic Systems, Inc. Lead specialty: Chemistry
Cleared Feb 01, 1985
SYSTE MATE TIBC HEM NO. 67225
K850128 · JMO
Em Diagnostic Systems, Inc.
Chemistry · 18d
Cleared Jan 28, 1985
SYSTE MATE IRON, HEM NO. 67224
K845020 · JIY
Em Diagnostic Systems, Inc.
Chemistry · 32d
Cleared Sep 28, 1984
SYSTEMATE A AMYLASE HEM 67204
K843645 · CIJ
Em Diagnostic Systems, Inc.
Chemistry · 11d
Cleared Sep 20, 1984
SYSTEMATE GPT 67209
K843334 · CKA
Em Diagnostic Systems, Inc.
Chemistry · 24d
Cleared Sep 20, 1984
SYSTEMATE GOT 67208
K843333 · CIT
Em Diagnostic Systems, Inc.
Chemistry · 24d
Cleared Sep 20, 1984
SYSTEMATE D-BILI 67213
K843329 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 24d
Cleared Sep 20, 1984
SYSTEMATE T-BILI 67212
K843328 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 24d
Cleared Sep 14, 1984
SYSTEMATE PHOSPHORUS 67217
K843330 · CEO
Em Diagnostic Systems, Inc.
Chemistry · 18d
Cleared Sep 14, 1984
SYSTEMATE CHOLESTEROL 67222
K843327 · CHH
Em Diagnostic Systems, Inc.
Chemistry · 18d
Cleared Sep 14, 1984
SYSTEMATE BUN HEM NO. 67221
K843326 · CDQ
Em Diagnostic Systems, Inc.
Chemistry · 18d
Cleared Sep 13, 1984
SYSTEMATE URIC ACID, HEM 67220
K843325 · KNK
Em Diagnostic Systems, Inc.
Chemistry · 17d
Cleared Sep 13, 1984
SYSTEMATE ALKALINE PHOSPHATASE-67203
K843270 · CJE
Em Diagnostic Systems, Inc.
Chemistry · 24d
Cleared Sep 13, 1984
SYSTEMATE LDH, 67210
K843269 · CFJ
Em Diagnostic Systems, Inc.
Chemistry · 24d
Cleared Sep 13, 1984
SYSTEMATE 2GT - 67207
K843268 · JQB
Em Diagnostic Systems, Inc.
Chemistry · 24d
Cleared Sep 07, 1984
SYSTEMATE CK-TOTAL - 67206
K843271 · CGS
Em Diagnostic Systems, Inc.
Chemistry · 18d
Cleared Aug 29, 1984
SYSTEMATE CALCIUM 67214
K843152 · CIC
Em Diagnostic Systems, Inc.
Chemistry · 19d
Cleared Aug 27, 1984
SYSTEMATE GLUCOSE 67215
K843151 · CGA
Em Diagnostic Systems, Inc.
Chemistry · 17d
Cleared Aug 27, 1984
SYSTEMATE GLUCOSE 67216
K843150 · CFR
Em Diagnostic Systems, Inc.
Chemistry · 17d
Cleared Aug 27, 1984
SYSTEMATE ALBUMIN
K843108 · CIX
Em Diagnostic Systems, Inc.
Chemistry · 20d
Cleared Aug 27, 1984
SYSTEMATE TOTAL PROTEIN 67218
K843107 · CEK
Em Diagnostic Systems, Inc.
Chemistry · 20d
Cleared Aug 27, 1984
SYSTEMATE TRIGLYCERIDE 67219
K843106 · CDT
Em Diagnostic Systems, Inc.
Chemistry · 20d
Cleared Aug 27, 1984
SYSTEMATE CREATININE 67223
K843105 · CGX
Em Diagnostic Systems, Inc.
Chemistry · 20d
Cleared Jul 06, 1984
ULTRA CHEM ENZYMATIC TRIGLYCERIDE
K842211 · CDT
Em Diagnostic Systems, Inc.
Chemistry · 32d
Cleared May 16, 1984
ULTRA CHEM ENZYMATIC TRIGLYCERIDE
K841471 · CDT
Em Diagnostic Systems, Inc.
Chemistry · 37d