Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Emd Chemicals, Inc. — Predicate Candidate Screening
62 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
31 daysmedian FDA review time
78 days90th percentile
62clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K031367 | DUOPATH VEROTOXINS GLISA TEST | Emd Chemicals, Inc. | 2004-01-23 | 268 | 0 |
| K990516 | ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS | Emd Chemicals, Inc. | 1999-03-31 | 41 | 3 |
| K981926 | ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS | Emd Chemicals, Inc. | 1998-07-22 | 50 | 0 |
| K973054 | ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS | Emd Chemicals, Inc. | 1997-10-01 | 47 | 0 |
| K951494 | AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR) | Emd Chemicals, Inc. | 1995-12-11 | 255 | 0 |
| K951750 | GLUCOSE TEST ITEM NUMBER 97375/94 | Emd Chemicals, Inc. | 1995-09-06 | 142 | 0 |
| K950234 | TOTAL PROTEIN TEST (TPRO) ITEM NUMBER: XXXXX/R1. R2 | Emd Chemicals, Inc. | 1995-06-14 | 152 | 0 |
| K950128 | TOTAL PROTEIN TEST (TPRO) ITEM XXXXX/R1. R2 | Emd Chemicals, Inc. | 1995-05-15 | 123 | 0 |
| K945322 | PHOSPHORUS TEST (PHOS) ITEM NUMBER 65416 | Emd Chemicals, Inc. | 1994-12-07 | 36 | 0 |
| K945368 | PHOSPHORUS TEST (PHOS) | Emd Chemicals, Inc. | 1994-12-02 | 43 | 0 |
| K840883 | UNIPAK 100 ANALYZER, 65156 & CHEMISTR | Emd Chemicals, Inc. | 1984-05-16 | 79 | 0 |
| K840477 | UNITIZED HEMATOLOGY SET 65132/93 | Emd Chemicals, Inc. | 1984-03-05 | 31 | 0 |
| K834294 | ELTRACHEM DIATRAC GLYCOSYLATED HEMOGLOB | Emd Chemicals, Inc. | 1984-01-24 | 47 | 0 |
| K833448 | EPOS CHEMISTRY ANALYZER 5060 & 6410 | Emd Chemicals, Inc. | 1983-12-22 | 78 | 0 |
| K833017 | SERUM IRON & TIBC#65084 & 65085 | Emd Chemicals, Inc. | 1983-11-03 | 58 | 0 |
| K832480 | TRUST RPR TITRATION CARD TEST #65145 | Emd Chemicals, Inc. | 1983-09-12 | 48 | 0 |
| K832479 | TRUST RPR CARD TEST #65144 | Emd Chemicals, Inc. | 1983-09-12 | 48 | 0 |
| K831027 | EXTRELUT QE EXTRACTION COLUMNS | Emd Chemicals, Inc. | 1983-05-16 | 47 | 0 |
| K831200 | IMMUNOHEMATOLOGICAL SALINE #97139 | Emd Chemicals, Inc. | 1983-05-09 | 28 | 0 |
| K830832 | RHEUMATOID FACTOR-RAPID CARD TEST #65114 | Emd Chemicals, Inc. | 1983-04-18 | 33 | 0 |
| K830241 | ULTRA CHEM BUN-UV #65080-65081 | Emd Chemicals, Inc. | 1983-04-05 | 70 | 0 |
| K830239 | ULTRA CHEM ENZYMATIC CHOLESTEROL OXIDA | Emd Chemicals, Inc. | 1983-04-05 | 70 | 0 |
| K830309 | ULTRA CHEM ENZYMATIC CHOLESTEROL OXIDASE | Emd Chemicals, Inc. | 1983-02-28 | 28 | 0 |
| K830308 | ULTRA ZYME PLUS GAMMA GT #65055 & 56 | Emd Chemicals, Inc. | 1983-02-28 | 28 | 0 |
| K830240 | ULTRAZYME PLUS GAMMA GT-MCA #65055-65056 | Emd Chemicals, Inc. | 1983-02-18 | 24 | 0 |
| K830238 | ULTRA CHEM CRESOLCAVERSACHEM #65082 | Emd Chemicals, Inc. | 1983-02-18 | 24 | 0 |
| K823883 | ULTRAZYME PLUS GAMMA-GT, #64959/65032 | Emd Chemicals, Inc. | 1983-01-28 | 32 | 0 |
| K823300 | BUN-UN CENTRIFICHUM 500, #65080/81 | Emd Chemicals, Inc. | 1983-01-09 | 65 | 0 |
| K823472 | ULTRA CHEM BAN-UV #65080 & 65081 | Emd Chemicals, Inc. | 1982-12-28 | 36 | 0 |
| K823402 | ULTRACHEM BUN-UV-GEM SAEC APPLI.#65080& | Emd Chemicals, Inc. | 1982-12-26 | 41 | 0 |
| K823354 | ULTRACHEM ENZYMATIC CHOLESTEROL OXIDASE | Emd Chemicals, Inc. | 1982-12-22 | 47 | 0 |
| K822937 | GLUCOSE/UREA NITROGEN STANDARD | Emd Chemicals, Inc. | 1982-11-05 | 32 | 0 |
| K822981 | MIDAS 1000 WRIGHT GIEMSA STAIN #66020 | Emd Chemicals, Inc. | 1982-10-27 | 19 | 0 |
| K822980 | MIDAS 1000 WRIGHT STAIN #66010 | Emd Chemicals, Inc. | 1982-10-27 | 19 | 0 |
| K822982 | MIDAS 100 HEMACOLOR STAIN #66030 | Emd Chemicals, Inc. | 1982-10-27 | 19 | 0 |
| K822473 | CALCIUM STANDARD, ITEM #65075 | Emd Chemicals, Inc. | 1982-09-17 | 31 | 0 |
| K822477 | CREATININE STANDARD #65072 | Emd Chemicals, Inc. | 1982-09-17 | 31 | 0 |
| K822474 | CHOLESTEROL STANDARD #65077 | Emd Chemicals, Inc. | 1982-09-14 | 28 | 0 |
| K822476 | PHOSPHOROUS STANDARD #65073 | Emd Chemicals, Inc. | 1982-09-14 | 28 | 0 |
| K822418 | ULTRACHEM ENZYMATIC CHOL. OXIDASE | Emd Chemicals, Inc. | 1982-09-14 | 34 | 0 |
| K822475 | TOTAL PROTEIN STANDARD, #65074 | Emd Chemicals, Inc. | 1982-09-14 | 28 | 0 |
| K822478 | ALBUMIN STANDARD, #65070 | Emd Chemicals, Inc. | 1982-09-14 | 28 | 0 |
| K822479 | BILIRUBIN CALIBRATOR #65071 | Emd Chemicals, Inc. | 1982-09-14 | 28 | 0 |
| K821475 | ULTRACHEM E-GLU #64976&65040 | Emd Chemicals, Inc. | 1982-06-25 | 38 | 0 |
| K821474 | ULTRACHEM URIC ACID AIDH #65047 | Emd Chemicals, Inc. | 1982-06-03 | 16 | 0 |
| K821472 | ULTRACHEM CREA #64972 | Emd Chemicals, Inc. | 1982-06-03 | 16 | 0 |
| K821473 | ULTRAZYME PLUS CKI, #64978,65027&65028 | Emd Chemicals, Inc. | 1982-06-03 | 16 | 0 |
| K821464 | CARDIOZYME PLUS CK-MB, #65045 | Emd Chemicals, Inc. | 1982-06-02 | 15 | 0 |
| K821465 | ULTRACHEM URIC ACID AIDH, #65047 | Emd Chemicals, Inc. | 1982-06-02 | 15 | 0 |
| K821463 | ULTRACHEM GLUC-DH, #65048 | Emd Chemicals, Inc. | 1982-06-02 | 15 | 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