Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Em Diagnostic Systems, Inc. · Predicate Candidate Screening
288 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
43 daysmedian FDA review time
93 days90th percentile
288clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K935181 | ASPARTATE AMINOTRANSFERASE (AST) TEST | Em Diagnostic Systems, Inc. | 1994-01-27 | 93 | 0 |
| K935180 | ALANINE AMINOTRANSFERASE (ALT) TEST | Em Diagnostic Systems, Inc. | 1994-01-13 | 79 | 0 |
| K935178 | EMDS PHOSPHOROUS (PHOS) TEST | Em Diagnostic Systems, Inc. | 1993-12-17 | 52 | 0 |
| K935179 | EMDS ALBUMIN (ALB) TEST | Em Diagnostic Systems, Inc. | 1993-12-17 | 52 | 0 |
| K935136 | CHOLESTEROL (CHOL) TEST ITEM NO. 65410 | Em Diagnostic Systems, Inc. | 1993-12-16 | 49 | 0 |
| K935174 | TOTAL PROTEIN TEST (TPRO) | Em Diagnostic Systems, Inc. | 1993-12-16 | 50 | 0 |
| K935176 | IRON TEST | Em Diagnostic Systems, Inc. | 1993-12-16 | 50 | 0 |
| K935177 | GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST | Em Diagnostic Systems, Inc. | 1993-12-16 | 51 | 0 |
| K935175 | LACTATE DEHYDROGENASE (LD) | Em Diagnostic Systems, Inc. | 1993-12-16 | 50 | 0 |
| K935183 | EMDS MAGNESIUM (MG) TEST | Em Diagnostic Systems, Inc. | 1993-12-09 | 43 | 0 |
| K935182 | EMDS ALKANINE PHOSPHATASE (ALP) TEST | Em Diagnostic Systems, Inc. | 1993-12-09 | 43 | 0 |
| K932158 | CALCIUM TEST ITEM NUMBER 65409 | Em Diagnostic Systems, Inc. | 1993-09-27 | 146 | 0 |
| K932162 | URIC ACID TEST ITEM NUMBER 65422 | Em Diagnostic Systems, Inc. | 1993-09-27 | 146 | 0 |
| K932159 | SYSTEMATE DIRECT BILIRUBIN CAT. NO. 65406 | Em Diagnostic Systems, Inc. | 1993-09-21 | 140 | 0 |
| K932161 | UREA NITROGEN TEST ITEM NUMBER 65408 | Em Diagnostic Systems, Inc. | 1993-09-08 | 127 | 0 |
| K931891 | TRIGLYCERIDES | Em Diagnostic Systems, Inc. | 1993-08-25 | 132 | 0 |
| K931583 | SILYL AMYL | Em Diagnostic Systems, Inc. | 1993-08-19 | 141 | 0 |
| K931582 | ETHYLIDENE AMYL | Em Diagnostic Systems, Inc. | 1993-08-19 | 141 | 0 |
| K931887 | BICARBONATE | Em Diagnostic Systems, Inc. | 1993-08-03 | 110 | 0 |
| K931889 | CREATINE KINASE TEST | Em Diagnostic Systems, Inc. | 1993-07-27 | 103 | 0 |
| K931888 | TOTAL BILIRUBIN | Em Diagnostic Systems, Inc. | 1993-07-27 | 103 | 0 |
| K931890 | GLUCOSE-HK TEST | Em Diagnostic Systems, Inc. | 1993-07-22 | 98 | 0 |
| K932160 | SYSTEMATE CREATININE TEST ITEM NUMBER 65413 | Em Diagnostic Systems, Inc. | 1993-07-09 | 66 | 0 |
| K930166 | IRON TEST #'S 42376/93,42324/R1A,42324/R1B,42324/R | Em Diagnostic Systems, Inc. | 1993-04-21 | 98 | 0 |
| K925101 | SYSTEMATE PLUS CALIBRATOR | Em Diagnostic Systems, Inc. | 1993-02-23 | 138 | 0 |
| K924703 | LACTATE DEHYDROGENASE (LD) TEST ITEM #65418 | Em Diagnostic Systems, Inc. | 1993-02-05 | 141 | 0 |
| K925188 | ABBOTT QUICKSTART LD-1, MODIFICATION | Em Diagnostic Systems, Inc. | 1993-02-05 | 120 | 0 |
| K924508 | CHOLESTEROL TEST ITEM# 42374/93, 42322/R1 | Em Diagnostic Systems, Inc. | 1993-01-28 | 146 | 0 |
| K924710 | TRIGLYCERIDES | Em Diagnostic Systems, Inc. | 1993-01-26 | 130 | 0 |
| K925002 | UREA NITROGEN TEST | Em Diagnostic Systems, Inc. | 1993-01-04 | 94 | 0 |
| K923959 | ALBUMIN TEST | Em Diagnostic Systems, Inc. | 1992-12-28 | 144 | 0 |
| K924711 | BICARBONATE | Em Diagnostic Systems, Inc. | 1992-12-03 | 76 | 0 |
| K924572 | EMDS GLUCOSE (GLU-HK) TEST, ITEM 65415 | Em Diagnostic Systems, Inc. | 1992-11-25 | 76 | 0 |
| K924574 | EMDS ALKALINE PHOSPHATASE (ALP) TEST | Em Diagnostic Systems, Inc. | 1992-11-09 | 60 | 0 |
| K924573 | SYSTEMATE PLUS TRIGLYCERIDE-GLYCEROL BLANKED TEST | Em Diagnostic Systems, Inc. | 1992-11-06 | 57 | 0 |
| K923733 | CHOLESTEROL TEST | Em Diagnostic Systems, Inc. | 1992-10-26 | 91 | 0 |
| K924599 | CREATININE-IP TEST, # 42375/93, 42323/R1, 42323/R2 | Em Diagnostic Systems, Inc. | 1992-10-15 | 34 | 0 |
| K924470 | TWO PART INORGANIC PHOSPHORUS TEST | Em Diagnostic Systems, Inc. | 1992-10-14 | 42 | 0 |
| K924704 | CREATINE KINASE (CK) TEST ITEM #65411 | Em Diagnostic Systems, Inc. | 1992-10-13 | 26 | 0 |
| K923257 | EMDS ALANINE AMINOTRANSFER TEST(ALT) TECH RA 1000 | Em Diagnostic Systems, Inc. | 1992-09-28 | 88 | 0 |
| K922947 | GAMMA GULTAMYL TRANSFERASE TEST | Em Diagnostic Systems, Inc. | 1992-09-28 | 102 | 0 |
| K923765 | SYSTEMATE URICACID TEST, TECHNICON RA 1000 | Em Diagnostic Systems, Inc. | 1992-09-22 | 56 | 0 |
| K923764 | SYSTEMATE PHOSPHORUS TEST TECHNICON RA 1000 | Em Diagnostic Systems, Inc. | 1992-09-22 | 56 | 0 |
| K922953 | SYSTEMATE CALCIUM TEST TECHNICON RA 1000 | Em Diagnostic Systems, Inc. | 1992-09-09 | 83 | 0 |
| K922857 | SYSTAMATE ASPARTATE AMINOTRANSFERASE TEST TECHNICO | Em Diagnostic Systems, Inc. | 1992-09-09 | 86 | 0 |
| K923083 | TOTAL BILIRUBIN CATALOG NO. 65407 | Em Diagnostic Systems, Inc. | 1992-09-09 | 76 | 0 |
| K923203 | SYSTEMATE CREATININE TEST | Em Diagnostic Systems, Inc. | 1992-09-09 | 76 | 0 |
| K923267 | SYSTEMATE TOTAL PROTEIN TEST, TECHNICON RA 1000 | Em Diagnostic Systems, Inc. | 1992-09-09 | 69 | 0 |
| K923677 | AMYLASE TEST | Em Diagnostic Systems, Inc. | 1992-09-09 | 49 | 0 |
| K922856 | SYSTEMATE DIRECT BILIRUBIN TEST TECHNICON RA 1000 | Em Diagnostic Systems, Inc. | 1992-09-09 | 86 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda