Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Data Medical Associates, Inc. · Predicate Candidate Screening
111 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
35 daysmedian FDA review time
85 days90th percentile
111clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K993098 | HDL-C/LDL-C CALIBRATOR, MODEL 1913-003 | Data Medical Associates, Inc. | 1999-10-08 | 22 | 0 |
| K971113 | DMA TRIGLYCERIDES PROCEDURES | Data Medical Associates, Inc. | 1997-05-29 | 63 | 0 |
| K961919 | DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDURE | Data Medical Associates, Inc. | 1996-07-01 | 45 | 0 |
| K955796 | IRON CALIBRATOR & CALIBRATION VERIFICATION SET | Data Medical Associates, Inc. | 1996-02-29 | 69 | 0 |
| K955302 | SERUM BICARBONATE/CARBON DIOXIDE | Data Medical Associates, Inc. | 1996-02-29 | 101 | 0 |
| K955300 | TOTAL BILIRUBIN PROCEDURE | Data Medical Associates, Inc. | 1995-12-20 | 30 | 0 |
| K952437 | DMA GLUCOSE HEXOKINASE U.V. PROCEDURE | Data Medical Associates, Inc. | 1995-10-03 | 131 | 0 |
| K946161 | DMA TOTAL CHOLESTEROL PROCEDURE | Data Medical Associates, Inc. | 1995-08-23 | 247 | 0 |
| K946354 | DMA UNSATURATED IRON BINDING CAPACITY PROCEDURE | Data Medical Associates, Inc. | 1995-05-08 | 129 | 0 |
| K946355 | DMA ALBUMIN PROCEDURE | Data Medical Associates, Inc. | 1995-03-01 | 61 | 0 |
| K944255 | DMA CALCIUM PLUS PROCEDURE | Data Medical Associates, Inc. | 1994-12-06 | 96 | 0 |
| K944462 | DMA IRON PROCEDURE | Data Medical Associates, Inc. | 1994-11-15 | 64 | 0 |
| K943241 | DMA GLUCOSE (OXIDASE) PROCEDURE | Data Medical Associates, Inc. | 1994-10-20 | 106 | 0 |
| K942424 | DMA MICROPROTEIN PROCEDURE | Data Medical Associates, Inc. | 1994-09-06 | 109 | 0 |
| K941063 | DNA TRIGLYCERIDE PROCEDURE | Data Medical Associates, Inc. | 1994-07-20 | 134 | 0 |
| K940010 | DMA AMYLASE (DEMAND) PROCEDURE | Data Medical Associates, Inc. | 1994-03-11 | 66 | 0 |
| K931559 | DMA AMYLASE PROCEDURE | Data Medical Associates, Inc. | 1993-10-28 | 212 | 0 |
| K915803 | DMA LD KINETIC PROCEDURE | Data Medical Associates, Inc. | 1992-03-18 | 85 | 0 |
| K902202 | DMA TRIGLYCERIDE (GPO) PROCEDURE | Data Medical Associates, Inc. | 1990-07-31 | 76 | 0 |
| K895717 | SODIUM AND POTASSIUM STANDARD | Data Medical Associates, Inc. | 1990-01-11 | 108 | 0 |
| K895718 | LITHIUM CONCENTRATE FOR A FLAME PHOTOMETER | Data Medical Associates, Inc. | 1989-10-19 | 24 | 0 |
| K890868 | DMA MICROPROTEIN PROCEDURE | Data Medical Associates, Inc. | 1989-03-20 | 27 | 0 |
| K890302 | CALCIUM PLUS PROCEDURE | Data Medical Associates, Inc. | 1989-02-27 | 35 | 0 |
| K881168 | CREATINE KINASE (CK) ISOENZYME MB | Data Medical Associates, Inc. | 1988-11-10 | 237 | 0 |
| K881761 | UNSATURATED IRON BINDING CAPACITY | Data Medical Associates, Inc. | 1988-07-08 | 74 | 0 |
| K881326 | HDL CHOLESTEROL PRECIPITATING PROCEDURE | Data Medical Associates, Inc. | 1988-05-27 | 59 | 0 |
| K881166 | DIRECT BILIRUBIN PROCEDURE | Data Medical Associates, Inc. | 1988-04-28 | 41 | 0 |
| K881167 | IRON PROCEDURE | Data Medical Associates, Inc. | 1988-04-28 | 41 | 0 |
| K880395 | TOTAL BILIRUBIN PROCEDURE RUN ON A DEMAND INSTRU. | Data Medical Associates, Inc. | 1988-03-15 | 46 | 0 |
| K880397 | DIRECT BILIRUBIN PROCEDURE RUN ON A AU5000 INSTRU. | Data Medical Associates, Inc. | 1988-03-15 | 46 | 0 |
| K880396 | TOTAL BILIRUBIN PROCEDURE RUN ON A AU5000 INSTRU. | Data Medical Associates, Inc. | 1988-03-15 | 46 | 0 |
| K874918 | IRON PROCEDURE | Data Medical Associates, Inc. | 1988-02-11 | 70 | 0 |
| K872891 | LACTATE DEHYDROGENASE ISOENZYME 1 | Data Medical Associates, Inc. | 1987-09-16 | 55 | 0 |
| K864825 | AMYLASE COLORIMETRIC PROCEDURE | Data Medical Associates, Inc. | 1987-02-20 | 73 | 0 |
| K870062 | BICARBONATE PROCEDURE | Data Medical Associates, Inc. | 1987-02-13 | 37 | 0 |
| K863265 | DIRECT BILIRUBIN PROCEDURE | Data Medical Associates, Inc. | 1986-10-24 | 60 | 0 |
| K863585 | CHLORIDE PROCEDURE | Data Medical Associates, Inc. | 1986-10-16 | 31 | 0 |
| K863587 | CREATINE PHOSPHOKINASE(CK) PROCEDURE | Data Medical Associates, Inc. | 1986-10-03 | 18 | 0 |
| K863255 | LACTATE DEHYDROGENASE(LD) PROCEDURE | Data Medical Associates, Inc. | 1986-10-03 | 39 | 0 |
| K863586 | GAMMA GLUTAMYL TRANSFERASE PROCEDURE | Data Medical Associates, Inc. | 1986-10-03 | 18 | 0 |
| K863261 | CREATININE PROCEDURE | Data Medical Associates, Inc. | 1986-10-02 | 38 | 0 |
| K863588 | AMYLASE PROCEDURE | Data Medical Associates, Inc. | 1986-09-29 | 14 | 0 |
| K863258 | TOTAL PROTEIN PROCEDURE | Data Medical Associates, Inc. | 1986-09-29 | 35 | 0 |
| K863268 | ALKALINE PHOSPHATASE PROCEDURE | Data Medical Associates, Inc. | 1986-09-29 | 35 | 0 |
| K863252 | CHOLESTEROL PROCEDURE | Data Medical Associates, Inc. | 1986-09-29 | 35 | 0 |
| K863254 | TRIGLYCERIDE (TRINDER) PROCEDURE | Data Medical Associates, Inc. | 1986-09-26 | 32 | 0 |
| K863251 | URIC ACID PROCEDURE | Data Medical Associates, Inc. | 1986-09-26 | 32 | 0 |
| K863257 | AST/GOT PROCEDURE | Data Medical Associates, Inc. | 1986-09-26 | 32 | 0 |
| K863256 | CALCIUM PROCEDURE | Data Medical Associates, Inc. | 1986-09-26 | 32 | 0 |
| K863259 | GLUCOSE HK PROCEDURE | Data Medical Associates, Inc. | 1986-09-26 | 32 | 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