Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Tech-Co, Inc. — Predicate Candidate Screening
36 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
40 daysmedian FDA review time
81 days90th percentile
36clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K921968 | IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TEST | Tech-Co, Inc. | 1996-06-28 | 1523 | 0 |
| K923376 | VISUAL HCG PREGNANCY TEST | Tech-Co, Inc. | 1992-10-01 | 84 | 0 |
| K920766 | T4 EIA BEAD ASSAY | Tech-Co, Inc. | 1992-04-17 | 58 | 0 |
| K920716 | DIRECT PREGNANCY TEST | Tech-Co, Inc. | 1992-03-24 | 35 | 0 |
| K902574 | POTASSIUM REAGENT SET | Tech-Co, Inc. | 1990-07-10 | 29 | 0 |
| K901561 | IRON/TOTAL IRON BINDING CAPACITY | Tech-Co, Inc. | 1990-05-17 | 44 | 0 |
| K883387 | ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD) | Tech-Co, Inc. | 1988-10-13 | 64 | 0 |
| K883683 | HEMOGLOBIN | Tech-Co, Inc. | 1988-10-06 | 38 | 0 |
| K883386 | CHLORIDE | Tech-Co, Inc. | 1988-10-06 | 57 | 0 |
| K881173 | ASPARTATE AMINOTRANSFERASE (COLORIMETRIC METHOD) | Tech-Co, Inc. | 1988-06-07 | 81 | 0 |
| K881172 | BILIRUBIN (DIRECT) | Tech-Co, Inc. | 1988-06-07 | 81 | 0 |
| K881626 | GAMMA-GLUTAMYL TRANSFERASE | Tech-Co, Inc. | 1988-05-27 | 45 | 0 |
| K881171 | PHOSPHORUS (INORGANIC) | Tech-Co, Inc. | 1988-04-28 | 38 | 0 |
| K880177 | ALKALINE PHOSPHATASE, THYMOLPHTHALEIN MONOPHOSPHAT | Tech-Co, Inc. | 1988-04-05 | 81 | 0 |
| K880629 | CREATININE | Tech-Co, Inc. | 1988-03-23 | 36 | 0 |
| K880630 | LACTATE DEHYDROGENASE (LDH-L) | Tech-Co, Inc. | 1988-03-16 | 29 | 0 |
| K880628 | TRIGLYCERIDES (GPO-TRINDER) | Tech-Co, Inc. | 1988-03-15 | 28 | 0 |
| K874846 | GLUCOSE (HEXOKINASE) | Tech-Co, Inc. | 1988-03-03 | 100 | 0 |
| K875071 | ASPARTATE AMINOTRANSFERASE AST/SGOT | Tech-Co, Inc. | 1988-02-18 | 71 | 0 |
| K880178 | CREATINE KINASE (COLORIMETRIC METHOD) | Tech-Co, Inc. | 1988-02-18 | 34 | 0 |
| K880176 | HDL CHOLESTEROL PRECIPITATING REAGENT | Tech-Co, Inc. | 1988-02-18 | 34 | 0 |
| K875069 | BILIRUBIN (TOTAL) | Tech-Co, Inc. | 1988-01-11 | 33 | 0 |
| K875070 | ALBUMIN, BROMCRESOL GREEN DYE-BINDING | Tech-Co, Inc. | 1988-01-11 | 33 | 0 |
| K874848 | LACTATE DEHYDROGENASE LDH-L | Tech-Co, Inc. | 1987-12-18 | 24 | 0 |
| K874847 | MAGNESIUM | Tech-Co, Inc. | 1987-12-18 | 24 | 0 |
| K864744 | CREATINE PHOSPHOKINASE (CK) | Tech-Co, Inc. | 1987-01-13 | 40 | 0 |
| K864905 | ALKALINE PHOSPHATASE | Tech-Co, Inc. | 1987-01-13 | 29 | 0 |
| K864742 | UREA NITROGEN(BUN), COLORIMETRIC METHOD | Tech-Co, Inc. | 1987-01-13 | 40 | 0 |
| K864743 | BIURET (COLORIMETRIC), TOTAL PROTEIN | Tech-Co, Inc. | 1987-01-13 | 40 | 0 |
| K864741 | CRESOLPHTHALEIN COMPLEXONE, CALCIUM | Tech-Co, Inc. | 1987-01-09 | 36 | 0 |
| K864906 | ALANINE AMINO TRANSFERASE ALT/SGPT | Tech-Co, Inc. | 1986-12-31 | 16 | 0 |
| K863925 | UREA NITROGEN(BUN) | Tech-Co, Inc. | 1986-11-24 | 47 | 0 |
| K863927 | CHOLESTEROL | Tech-Co, Inc. | 1986-11-24 | 47 | 0 |
| K863924 | URIC ACID | Tech-Co, Inc. | 1986-11-24 | 47 | 0 |
| K863923 | TRIGLYCERIDES | Tech-Co, Inc. | 1986-11-24 | 47 | 0 |
| K863926 | GLUCOSE OXIDASE | Tech-Co, Inc. | 1986-11-13 | 36 | 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