Company ยท US
Em Diagnostic Systems, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1984 to 1994. Name variants (Inc, Corp, punctuation) are merged.
288510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CIG | Diazo Colorimetry, Bilirubin | 21 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 14 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 13 |
| CEK | Biuret (Colorimetric), Total Protein | 10 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 10 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 10 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 10 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 10 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 10 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 10 |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 10 |
| JQB | Kinetic Method, Gamma-Glutamyl Transpeptidase | 10 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 9 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 9 |
| CFR | Hexokinase, Glucose | 7 |
| CIC | Cresolphthalein Complexone, Calcium | 7 |
| JFJ | Catalytic Methods, Amylase | 7 |
| JGJ | Photometric Method, Magnesium | 7 |
| JIY | Photometric Method, Iron (Non-Heme) | 7 |
| KHS | Enzymatic, Carbon-Dioxide | 7 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 27, 1994 | K935181 | ASPARTATE AMINOTRANSFERASE (AST) TEST Em Diagnostic Systems, Inc. | CIT |
| Jan 13, 1994 | K935180 | ALANINE AMINOTRANSFERASE (ALT) TEST Em Diagnostic Systems, Inc. | CKA |
| Dec 17, 1993 | K935179 | EMDS ALBUMIN (ALB) TEST Em Diagnostic Systems, Inc. | CIX |
| Dec 17, 1993 | K935178 | EMDS PHOSPHOROUS (PHOS) TEST Em Diagnostic Systems, Inc. | CEO |
| Dec 16, 1993 | K935177 | GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST Em Diagnostic Systems, Inc. | JQB |
| Dec 16, 1993 | K935176 | IRON TEST Em Diagnostic Systems, Inc. | JIY |
| Dec 16, 1993 | K935175 | LACTATE DEHYDROGENASE (LD) Em Diagnostic Systems, Inc. | CFJ |
| Dec 16, 1993 | K935174 | TOTAL PROTEIN TEST (TPRO) Em Diagnostic Systems, Inc. | CEK |
| Dec 16, 1993 | K935136 | CHOLESTEROL (CHOL) TEST ITEM NO. 65410 Em Diagnostic Systems, Inc. | CHH |
| Dec 9, 1993 | K935183 | EMDS MAGNESIUM (MG) TEST Em Diagnostic Systems, Inc. | JGJ |
| Dec 9, 1993 | K935182 | EMDS ALKANINE PHOSPHATASE (ALP) TEST Em Diagnostic Systems, Inc. | CJE |
| Sep 27, 1993 | K932162 | URIC ACID TEST ITEM NUMBER 65422 Em Diagnostic Systems, Inc. | CDO |
| Sep 27, 1993 | K932158 | CALCIUM TEST ITEM NUMBER 65409 Em Diagnostic Systems, Inc. | CIC |
| Sep 21, 1993 | K932159 | SYSTEMATE DIRECT BILIRUBIN CAT. NO. 65406 Em Diagnostic Systems, Inc. | CIG |
| Sep 8, 1993 | K932161 | UREA NITROGEN TEST ITEM NUMBER 65408 Em Diagnostic Systems, Inc. | CDQ |
| Aug 25, 1993 | K931891 | TRIGLYCERIDES Em Diagnostic Systems, Inc. | CDT |
| Aug 19, 1993 | K931583 | SILYL AMYL Em Diagnostic Systems, Inc. | JFJ |
| Aug 19, 1993 | K931582 | ETHYLIDENE AMYL Em Diagnostic Systems, Inc. | JFJ |
| Aug 3, 1993 | K931887 | BICARBONATE Em Diagnostic Systems, Inc. | KHS |
| Jul 27, 1993 | K931889 | CREATINE KINASE TEST Em Diagnostic Systems, Inc. | CGS |
| Jul 27, 1993 | K931888 | TOTAL BILIRUBIN Em Diagnostic Systems, Inc. | CIG |
| Jul 22, 1993 | K931890 | GLUCOSE-HK TEST Em Diagnostic Systems, Inc. | CFR |
| Jul 9, 1993 | K932160 | SYSTEMATE CREATININE TEST ITEM NUMBER 65413 Em Diagnostic Systems, Inc. | CGX |
| Apr 21, 1993 | K930166 | IRON TEST #'S 42376/93,42324/R1A,42324/R1B,42324/R Em Diagnostic Systems, Inc. | JIY |
| Feb 23, 1993 | K925101 | SYSTEMATE PLUS CALIBRATOR Em Diagnostic Systems, Inc. | JIX |
| Feb 5, 1993 | K925188 | ABBOTT QUICKSTART LD-1, MODIFICATION Em Diagnostic Systems, Inc. | JGF |
| Feb 5, 1993 | K924703 | LACTATE DEHYDROGENASE (LD) TEST ITEM #65418 Em Diagnostic Systems, Inc. | CFJ |
| Jan 28, 1993 | K924508 | CHOLESTEROL TEST ITEM# 42374/93, 42322/R1 Em Diagnostic Systems, Inc. | CHH |
| Jan 26, 1993 | K924710 | TRIGLYCERIDES Em Diagnostic Systems, Inc. | CDT |
| Jan 4, 1993 | K925002 | UREA NITROGEN TEST Em Diagnostic Systems, Inc. | CDQ |
| Dec 28, 1992 | K923959 | ALBUMIN TEST Em Diagnostic Systems, Inc. | CIX |
| Dec 3, 1992 | K924711 | BICARBONATE Em Diagnostic Systems, Inc. | KHS |
| Nov 25, 1992 | K924572 | EMDS GLUCOSE (GLU-HK) TEST, ITEM 65415 Em Diagnostic Systems, Inc. | CFR |
| Nov 9, 1992 | K924574 | EMDS ALKALINE PHOSPHATASE (ALP) TEST Em Diagnostic Systems, Inc. | CJE |
| Nov 6, 1992 | K924573 | SYSTEMATE PLUS TRIGLYCERIDE-GLYCEROL BLANKED TEST Em Diagnostic Systems, Inc. | CDT |
| Oct 26, 1992 | K923733 | CHOLESTEROL TEST Em Diagnostic Systems, Inc. | CHH |
| Oct 15, 1992 | K924599 | CREATININE-IP TEST, # 42375/93, 42323/R1, 42323/R2 Em Diagnostic Systems, Inc. | CGX |
| Oct 14, 1992 | K924470 | TWO PART INORGANIC PHOSPHORUS TEST Em Diagnostic Systems, Inc. | CEO |
| Oct 13, 1992 | K924704 | CREATINE KINASE (CK) TEST ITEM #65411 Em Diagnostic Systems, Inc. | CGS |
| Sep 28, 1992 | K923257 | EMDS ALANINE AMINOTRANSFER TEST(ALT) TECH RA 1000 Em Diagnostic Systems, Inc. | CKA |
| Sep 28, 1992 | K922947 | GAMMA GULTAMYL TRANSFERASE TEST Em Diagnostic Systems, Inc. | JQB |
| Sep 22, 1992 | K923765 | SYSTEMATE URICACID TEST, TECHNICON RA 1000 Em Diagnostic Systems, Inc. | CDO |
| Sep 22, 1992 | K923764 | SYSTEMATE PHOSPHORUS TEST TECHNICON RA 1000 Em Diagnostic Systems, Inc. | CEO |
| Sep 9, 1992 | K923677 | AMYLASE TEST Em Diagnostic Systems, Inc. | JFJ |
| Sep 9, 1992 | K923267 | SYSTEMATE TOTAL PROTEIN TEST, TECHNICON RA 1000 Em Diagnostic Systems, Inc. | CEK |
| Sep 9, 1992 | K923203 | SYSTEMATE CREATININE TEST Em Diagnostic Systems, Inc. | CGX |
| Sep 9, 1992 | K923083 | TOTAL BILIRUBIN CATALOG NO. 65407 Em Diagnostic Systems, Inc. | CIG |
| Sep 9, 1992 | K922953 | SYSTEMATE CALCIUM TEST TECHNICON RA 1000 Em Diagnostic Systems, Inc. | CIL |
| Sep 9, 1992 | K922857 | SYSTAMATE ASPARTATE AMINOTRANSFERASE TEST TECHNICO Em Diagnostic Systems, Inc. | CIT |
| Sep 9, 1992 | K922856 | SYSTEMATE DIRECT BILIRUBIN TEST TECHNICON RA 1000 Em Diagnostic Systems, Inc. | CIG |
Newest 50 of 288.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||