Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Alpkem Corp. — Predicate Candidate Screening
33 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
25 daysmedian FDA review time
67 days90th percentile
33clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K894011 | TOTAL GALACTOSE | Alpkem Corp. | 1990-01-11 | 219 | 0 |
| K891070 | PHENYLALANINE (NINHYDRIN REACTION) | Alpkem Corp. | 1989-10-27 | 240 | 0 |
| K890334 | TOTAL CHOLESTEROL REAGENT | Alpkem Corp. | 1989-05-03 | 100 | 0 |
| K890337 | TRIGLYCERIDES - GPO REAGENT | Alpkem Corp. | 1989-03-09 | 45 | 0 |
| K890336 | GLUCOSE (GOD) REAGENT | Alpkem Corp. | 1989-02-27 | 35 | 0 |
| K890335 | SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU. | Alpkem Corp. | 1989-02-17 | 25 | 0 |
| K890332 | RFA/2 RAPID FLOW ANALYZER W/COMPUTER | Alpkem Corp. | 1989-02-17 | 25 | 0 |
| K890333 | ALBUMIN REAGENT | Alpkem Corp. | 1989-02-17 | 25 | 0 |
| K883020 | RFA-300 RAPID FLOW ANALYZER W/COMPUTER | Alpkem Corp. | 1988-09-02 | 45 | 0 |
| K860367 | MAGNESIUM (SUBSTRATE, ENZYME, REAGENT) | Alpkem Corp. | 1986-04-11 | 67 | 0 |
| K852005 | MG REAGENT | Alpkem Corp. | 1985-06-25 | 49 | 0 |
| K851990 | INTERNAL STANDARD SOLUTION, EXTERNAL STANDARD SOLU | Alpkem Corp. | 1985-06-25 | 49 | 0 |
| K852002 | CA BUFFER CA DYE | Alpkem Corp. | 1985-06-25 | 49 | 0 |
| K852001 | AMY REAGENT | Alpkem Corp. | 1985-06-10 | 34 | 0 |
| K852006 | TP BIURET REAGENT | Alpkem Corp. | 1985-06-10 | 34 | 0 |
| K851999 | G-GT REAGENT | Alpkem Corp. | 1985-06-10 | 34 | 0 |
| K851994 | AST ASPARTATE AMINOTRANSFERASE REAGENT | Alpkem Corp. | 1985-06-03 | 27 | 0 |
| K852003 | IP ACID REAGENT IP MOLY BDATE REAGENT | Alpkem Corp. | 1985-05-31 | 24 | 0 |
| K851996 | LD-L REAGENT | Alpkem Corp. | 1985-05-31 | 24 | 0 |
| K851997 | LD-P REAGENT | Alpkem Corp. | 1985-05-30 | 23 | 0 |
| K852007 | ALB BCG REAGENT | Alpkem Corp. | 1985-05-30 | 23 | 0 |
| K851993 | CRE BUFFER CRE DYE | Alpkem Corp. | 1985-05-30 | 23 | 0 |
| K852009 | T-CHO REAGENT | Alpkem Corp. | 1985-05-30 | 23 | 0 |
| K852000 | CK-NAC REAGENT | Alpkem Corp. | 1985-05-30 | 23 | 0 |
| K852010 | TGL REAGENT | Alpkem Corp. | 1985-05-30 | 23 | 0 |
| K851995 | ALT (ALANINE AMINO-THRANSFERASE)REAGENT | Alpkem Corp. | 1985-05-30 | 23 | 0 |
| K851998 | ALP(ALKALINE)(PHOSPHATASE) REAGENT | Alpkem Corp. | 1985-05-30 | 23 | 0 |
| K852008 | T-BIL REAGENT, D-BIL REAGENT, SODIUM NITRITE & SUL | Alpkem Corp. | 1985-05-30 | 23 | 0 |
| K851991 | UN(UREASE)REAGENT UN(A-KETO)REAGENT | Alpkem Corp. | 1985-05-29 | 22 | 0 |
| K852004 | UA(URICASE) REAGENT | Alpkem Corp. | 1985-05-29 | 22 | 0 |
| K851992 | GLU(GOD) REAGENT | Alpkem Corp. | 1985-05-29 | 22 | 0 |
| K851638 | CLINALYZER MODEL VX-1000 | Alpkem Corp. | 1985-05-13 | 24 | 0 |
| K851542 | RFA-300 RAPID FLOW ANALYZER W/COMPUTER | Alpkem Corp. | 1985-05-10 | 24 | 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