Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Macomb Chemical Co. · Predicate Candidate Screening
23 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
40 daysmedian FDA review time
93 days90th percentile
23clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K830095 | RAPID CHEM ANALYZER II | Macomb Chemical Co. | 1983-01-28 | 17 | 0 |
| K823720 | SPECTROPHOTOMETER | Macomb Chemical Co. | 1983-01-07 | 28 | 0 |
| K810958 | GLYCOHEMOGLOBIN | Macomb Chemical Co. | 1981-09-16 | 161 | 0 |
| K801086 | P-NITROPHENYL PHOSPHATE | Macomb Chemical Co. | 1980-05-28 | 21 | 0 |
| K800719 | ENZYMATIC UREA NITROGEN REAGENT SET REVI | Macomb Chemical Co. | 1980-05-08 | 38 | 0 |
| K800720 | MACOMB NAD-NICOTINAMIDE ADENINE DINUCLEO | Macomb Chemical Co. | 1980-04-21 | 21 | 0 |
| K792532 | GLUCOSE (HEXOKINASE) REAGENT SET | Macomb Chemical Co. | 1980-01-11 | 35 | 0 |
| K792533 | CREATINE PHOSPHOKINASE (CPK) REAGENT SET | Macomb Chemical Co. | 1980-01-11 | 35 | 0 |
| K791669 | GLUCOSE OXIDASE REAGENT SET | Macomb Chemical Co. | 1979-09-24 | 27 | 0 |
| K791511 | ENZYMATIC REAGENT SET, 4X250 ML. | Macomb Chemical Co. | 1979-09-04 | 40 | 0 |
| K791119 | MACOMB NORMAL CONTROL SERUM | Macomb Chemical Co. | 1979-07-30 | 45 | 0 |
| K790947 | AUTO ENZYMATIC CHOLESTEROL | Macomb Chemical Co. | 1979-06-28 | 41 | 0 |
| K790371 | MACOMB LIPID CONTROL | Macomb Chemical Co. | 1979-04-04 | 41 | 0 |
| K790065 | ALKALINE PHOSPHATASE | Macomb Chemical Co. | 1979-02-21 | 37 | 0 |
| K781128 | LDH (UV KINETIC) | Macomb Chemical Co. | 1978-08-10 | 41 | 0 |
| K780447 | URIC ACID REFERENCE SERA | Macomb Chemical Co. | 1978-06-22 | 94 | 0 |
| K780659 | HDL CHOLESTEROL | Macomb Chemical Co. | 1978-06-13 | 54 | 0 |
| K780534 | UREA NITROGEN (ENZYMATIC) | Macomb Chemical Co. | 1978-05-19 | 46 | 0 |
| K780351 | NORMAL UNASSAYED CONTROL SERA | Macomb Chemical Co. | 1978-04-24 | 52 | 0 |
| K780013 | SERUM GLUTAMIC OXALOACETIC TRANSAMINASE | Macomb Chemical Co. | 1978-01-30 | 27 | 0 |
| K771820 | ENZYMATIC CHOLESTEROL | Macomb Chemical Co. | 1977-10-19 | 26 | 0 |
| K770993 | TRIGLYCERIDE REAGENT SET | Macomb Chemical Co. | 1977-09-02 | 93 | 0 |
| K770991 | SERUM GLUTAMIC PYRUVIC TRANSAMINASE | Macomb Chemical Co. | 1977-08-02 | 62 | 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